Pure Global
Home/Indonesia Database/Authorized Representative
🇮🇩

PT. ANDAMAN MEDICAL INDONESIA

Authorized Representative in Indonesia

Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma
279 Products Represented
87 Manufacturers
Total Products
279
Manufacturers
87
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
39 products
14.0%
Kelas Resiko : B
87 products
31.2%
Kelas Resiko : C
117 products
41.9%
Kelas Resiko : D
36 products
12.9%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (279)
Complete portfolio registered with BPOM

NETROD™ Radio Frequency Renal Ablation Catheter

Manufacturer:

SHANGHAI GOLDEN LEAF MEDTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 11, 2025

BONEUNION MEDICAL Upper Limb Plate

Manufacturer:

BONEUNION (XIAMEN) MEDICAL DEVICE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 5, 2025

INNOLCON Ultrasonic Surgical System

Manufacturer:

INNOLCON MEDICAL TECHNOLOGY (SUZHOU) CO., LTD. (BUILDING 10)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 30, 2025

NETROD™ Radio Frequency Renal Ablation Device

Manufacturer:

SHANGHAI GOLDEN LEAF MEDTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 22, 2025

PERMEADERM Biosynthetic Wound Matrix

Manufacturer:

TRELLEBORG SEALING SOLUTIONS US, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 19, 2025

PERMEADERM Biosynthetic Wound Matrix

Manufacturer:

TRELLEBORG SEALING SOLUTIONS US, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 19, 2025

PHONAK TERRA BTE-M

Manufacturer:

SONOVA AT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2025

PHONAK TERRA+ BTE-M

Manufacturer:

SONOVA AT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2025

PHONAK TERRA+ BTE-UP

Manufacturer:

SONOVA AT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2025

PHONAK TERRA+ RIC-312

Manufacturer:

SONOVA AT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2025

PHONAK NAIDA L50-SP

Manufacturer:

SONOVA AT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2025

PHONAK NAIDA L90-SP

Manufacturer:

SONOVA AT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2025

PHONAK NAIDA L50-UP

Manufacturer:

SONOVA AT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

PHONAK NAIDA L90-UP

Manufacturer:

SONOVA AT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

PHONAK NAIDA L90-PR

Manufacturer:

SONOVA AT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

ON-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft

Manufacturer:

ON-X LIFE TECHNOLOGIES, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 13, 2025

PHONAK NAIDA L50-PR

Manufacturer:

SONOVA AT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 9, 2025

BIO-RAD Monolisa HBs Ag ULTRA

Manufacturer:

BIO-RAD (STEENVOORDE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 13, 2024

BIO-RAD Genscreen ULTRA HIV Ag-Ab

Manufacturer:

BIO-RAD (STEENVOORDE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 5, 2024

MITRIS RESILIA Mitral Valve

Manufacturer:

EDWARDS LIFESCIENCES LLC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 3, 2024

DNlite-DKD uPTM-FetA ELISA Kit

Manufacturer:

BIO PREVENTIVE MEDICINE CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

HUGEMED Flexible Video Ureterorenoscope

Manufacturer:

SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2024

BIO-RAD Monolisa HCV Ag-Ab Ultra V2

Manufacturer:

BIO-RAD (STEENVOORDE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 20, 2024

INNOLCON Phacoemulsification Surgical System

Manufacturer:

INNOLCON MEDICAL TECHNOLOGY (SUZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2024

UROMEDTECH UROMASTER® ADVENTURE

Manufacturer:

UROMEDTECH PTE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2024

JULAINE

Manufacturer:

MEDICAGO AB

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 13, 2024

BIO-RAD ID-DiaPanel-P

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 11, 2024

BIO-RAD ID-Dia (Diego) Positive

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 9, 2024

BIO-RAD ID-DiaCell ABO A1, B

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 9, 2024

BIO-RAD DiaClon RhD + Phenotype

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 9, 2024

CORINA Silicone Rubber Uterine Drug-Eluting Stent System

Manufacturer:

PUYI (SHANGHAI) BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 3, 2024

INNOLCON Phacoemulsification Surgical System

Manufacturer:

INNOLCON MEDICAL TECHNOLOGY (SUZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2024

BIO-RAD Syphilis Total Ab

Manufacturer:

BIO-RAD ( STEENVORDE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 28, 2024

PROLUS Monofilament Propylene

Manufacturer:

TI MEDICAL PRIVATE LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 21, 2024

ABL90 Sensor Cassette SC90 Ki BG, LYT, MET, UREA, CREA, OXI + QC

Manufacturer:

RADIOMETER MEDICAL APS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 21, 2024

SILKUS Braided Coated Silk

Manufacturer:

TI MEDICAL PRIVATE LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 21, 2024

SOLUS Braided Coated Polyglycolic Acid

Manufacturer:

TI MEDICAL PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 15, 2024

ABL90 Sensor Cassette SC90 BG, LYT, OXI + QC

Manufacturer:

RADIOMETER MEDICAL APS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2024

ABL90 Sensor Cassette SC90 BG, LYT, MET, OXI + QC

Manufacturer:

RADIOMETER MEDICAL APS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2024

ABL90 Sensor Cassette SC90 BG, LYT, MET, Hb + QC

Manufacturer:

RADIOMETER MEDICAL APS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2024

DODODOTS Acne Patch

Manufacturer:

WENZHOU CELECARE MEDICAL INSTRUMENTS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 10, 2024

SOLUS-910 Braided Coated Poly (Glycolide-Co-L-Lactide)/Polyglactin-910

Manufacturer:

TI MEDICAL PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 10, 2024

ABL90 Solution Pack Ki

Manufacturer:

RADIOMETER MEDICAL APS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

ABL90 Solution Pack Ki

Manufacturer:

RADIOMETER SOLUTIONS SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

ABL90 FLEX Solution Pack

Manufacturer:

RADIOMETER SOLUTIONS SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

ABL90 FLEX Solution Pack

Manufacturer:

RADIOMETER MEDICAL APS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 8, 2024

ABL90 FLEX PLUS

Manufacturer:

RADIOMETER MEDICAL APS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

NYLUS Monofilament Polyamide

Manufacturer:

TI MEDICAL PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 7, 2024

ABL90 FLEX

Manufacturer:

RADIOMETER MEDICAL APS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

BIOPANDA NT-proBNP Rapid Test

Manufacturer:

BIOPANDA REAGENTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 24, 2024

P Flex Ureteral Stent & Set

Manufacturer:

BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 23, 2024

Bluthane Ureteral Stent & Set

Manufacturer:

BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2024

TCM5 Basic Monitor

Manufacturer:

PLEXUS SERVICES RO S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2024

PVmed Contouring Software

Manufacturer:

GUANGZHOU PERCEPTION VISION MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2024

DENSSIFLO PTBD Catheter

Manufacturer:

BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 12, 2024

BLUE TAKE Guidewire

Manufacturer:

BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 10, 2024

BLUE NEEM Percutaneous Nephrostomy Drainage Set - Pigtail

Manufacturer:

BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 6, 2024

PLINEST FAST Polynucleotides Intradermal Gel

Manufacturer:

MASTELLI S.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 4, 2024

PLINEST Polynucleotides Intradermal Gel

Manufacturer:

MASTELLI S.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 27, 2024

DENSSICATH Multi-Purpose Drainage Catheter & Set

Manufacturer:

BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 26, 2024

EDWARDS Bioprostheses Heart Valve Accessories Use With Model 11400M

Manufacturer:

EDWARDS LIFESCIENCES LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 13, 2024

SCHÖLLY NIR FI Light Source

Manufacturer:

SCHÖLLY FIBEROPTIC GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2024

PSLOVE BackHeat

Manufacturer:

TAIZHOU BRANCH OF SHANGHAI YINGDU INDUSTRY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 13, 2024

BLUE NEEM Ureteral Catheter

Manufacturer:

BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

PROVIDED Universal Bur Holder

Manufacturer:

VERSAH LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 7, 2024

SCHÖLLY Cameras

Manufacturer:

SCHOLLY FIBEROPTIC GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2024

VERSAH Tapered Pilot Drill

Manufacturer:

VERSAH LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 4, 2024

PROVIDED Densah Burs

Manufacturer:

VERSAH LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 4, 2024

PROVIDED Parallel Pins

Manufacturer:

VERSAH LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 4, 2024

PRAVEZA Ureteral Access Sheath

Manufacturer:

BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 1, 2024

SCHÖLLY Light Source

Manufacturer:

SCHOLLY FIBEROPTIC GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 31, 2024

PICOCAREMAJESTY

Manufacturer:

WON TECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

OLIGIO

Manufacturer:

WON TECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

Oligio Kiss

Manufacturer:

WON TECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

INNO-LiPA HPV Genotyping Extra II Amp <20T, CE>

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

INNO-LiPA HPV Genotyping Extra II <20T,CE>

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

WETLING WMCS - Wireless Micro Current Stimulation

Manufacturer:

WETLING EU APS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 28, 2024

BLOOD MenstruHeat

Manufacturer:

TAIZHOU BRANCH OF SHANGHAI YINGDU INDUSTRY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 28, 2024

N QUADRA Stone Basket

Manufacturer:

BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 27, 2024

XPECTVISION Digital Intraoral X-ray Sensor

Manufacturer:

SHENZHEN XPECTVISION TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 24, 2024

Ureteral Dilators

Manufacturer:

BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 22, 2024

OPTICORE Biopsy Gun - Fully Automatic

Manufacturer:

BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 22, 2024

CYTOCORE Biopsy Gun - Semi Automatic

Manufacturer:

BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 22, 2024

EYEOP-PACK

Manufacturer:

EYE TECH CARE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 14, 2024

BOTTOM BOT

Manufacturer:

RED&BLUE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

PERMEADERM Biosynthetic Wound Matrix

Manufacturer:

TRELLEBORG SEALING SOLUTIONS US, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 6, 2024

VUNO Med - Chest X-ray

Manufacturer:

VUNO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 29, 2024

VUNO Med - Fundus AI

Manufacturer:

VUNO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 29, 2024

VUNO Med - LungCT AI

Manufacturer:

VUNO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 29, 2024

VUNO Med - DeepBrain

Manufacturer:

VUNO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 29, 2024

CELLO Audiometer

Manufacturer:

INVENTIS S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2024

INNO-LIA HIV I/II Score

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 22, 2024

INVENTIS Middle Ear Analyzer Viola

Manufacturer:

INVENTIS S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

REMISSION 1°C

Manufacturer:

ADIPOLABS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2024

INVENTIS Middle Ear Analyzer Flute Basic

Manufacturer:

INVENTIS S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 2, 2024

INVENTIS Middle Ear Analyzer Clarinet Plus

Manufacturer:

INVENTIS S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 2, 2024

INVENTIS Piccolo Speech

Manufacturer:

INVENTIS S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 2, 2024

SPINECOR Dynamic Corrective Brace

Manufacturer:

THE SPINECORPORATION LIMITED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 29, 2024

TITAN Optimax Activ Titanium-NO Active Coronary Stent

Manufacturer:

HEXACATH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 29, 2024

TIMPANI Handheld Tympanometer / Screening Audiometer

Manufacturer:

INVENTIS S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2024

TITAN OPTIMAX Titanium-NO Active Coronary Stent

Manufacturer:

HEXACATH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 24, 2024

INNOTEST β-AMYLOID(1-40)

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 13, 2024

INNOTEST PHOSPHO-TAU (181P)

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 13, 2024

INNO-LIA HCV Score

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 7, 2024

MEDIT Intraoral Scanner i600

Manufacturer:

MEDIT CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2024

MEDIT Intraoral Scanner i700

Manufacturer:

MEDIT CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 16, 2024

DOUBLE MEDICAL Hip Joint Prosthesis

Manufacturer:

DOUBLE MEDICAL TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 14, 2024

INNOTEST β-AMYLOID(1-42)

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2024

INNOTEST hTau Ag

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2024

Tendigo

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 9, 2024

CARPENTIER-EDWARDS PERIMOUNT Magna Ease Pericardial Bioprosthesis

Manufacturer:

EDWARDS LIFESCIENCES COSTA RICA S.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 28, 2023

BLOOD KneeHeat

Manufacturer:

TAIZHOU BRANCH OF SHANGHAI YINGDU INDUSTRY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 17, 2023

On-X Aortic Prosthetic Heart Valve - Anatomic Sewing Ring, Extended Holder

Manufacturer:

ON-X LIFE TECHNOLOGIES, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 10, 2023

LUCA V-Defense Nasal Spray

Manufacturer:

LUCA AICELL, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2023

On-X® Prosthetic Heart Valve Instruments

Manufacturer:

ON-X LIFE TECHNOLOGIES, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 4, 2023

ON-X® Conform-X® Aortic Prosthetic Heart Valve – Extended Holder

Manufacturer:

ON-X LIFE TECHNOLOGIES, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 4, 2023

INSPIRIS RESILIA Aortic Valve

Manufacturer:

EDWARDS LIFESCIENCES (SINGAPORE) PTE. LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 18, 2023

On-X Aortic Prosthetic Heart Valve – Extended Holder

Manufacturer:

ON-X LIFE TECHNOLOGIES, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 18, 2023

INSPIRIS RESILIA Aortic Valve

Manufacturer:

EDWARDS LIFESCIENCES LLC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 18, 2023

CARPENTIER-EDWARDS PERIMOUNT Magna Ease Pericardial Bioprosthesis

Manufacturer:

EDWARDS LIFESCIENCES (SINGAPORE) PTE. LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 18, 2023

Carpentier-Edwards Physio II Annuloplasty Ring

Manufacturer:

EDWARDS LIFESCIENCES LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2023

Carpentier-Edwards Physio Annuloplasty Ring

Manufacturer:

EDWARDS LIFESCIENCES LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2023

ON-X Mitral Prosthetic Heart Valve

Manufacturer:

ON-X LIFE TECHNOLOGIES, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 14, 2023

LORIENT No.6 Cross-linked Hyaluronic acid with Lidocaine

Manufacturer:

JOONGHUN PHARMACEUTICAL CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 14, 2023

On-X® Conform-X® Mitral Prosthetic Heart Valve

Manufacturer:

ON-X LIFE TECHNOLOGIES, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 14, 2023

LORIENT No.4 Cross-linked Hyaluronic acid with Lidocaine

Manufacturer:

JOONGHUN PHARMACEUTICAL CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 14, 2023

LORIENT No.2 Cross-linked Hyaluronic acid with Lidocaine

Manufacturer:

JOONGHUN PHARMACEUTICAL CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 14, 2023

EDWARDS LIFESCIENCES Annuloplasty Rings Accessories Sizers Use with models 4500, 4600, 4900, 6200

Manufacturer:

EDWARDS LIFESCIENCES LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 13, 2023

BLOOD Panty Pads 50cm (L-XL)

Manufacturer:

QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 13, 2023

EDWARDS LIFESCIENCES Disposable Handle

Manufacturer:

EDWARDS LIFESCIENCES LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 13, 2023

BLOOD Sanitary Pads 41 cm

Manufacturer:

QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 13, 2023

PANTHER HEALTHCARE Circular Stapler

Manufacturer:

B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

CARPENTIER-EDWARDS Bioprostheses Accessories Use With model 3000, 3300TFX, 8300AB, 8300KITB, 11500A

Manufacturer:

EDWARDS LIFESCIENCES LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 6, 2023

PANTHER HEALTHCARE Linear Stapler and Reloading Units

Manufacturer:

B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2023

EDWARDS LIFESCIENCES Annuloplasty Rings Accessories Use with models 4100, 4400, 4450, 4600, 5200

Manufacturer:

EDWARDS LIFESCIENCES LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 6, 2023

Cosgrove-Edwards Annuloplasty System

Manufacturer:

EDWARDS LIFESCIENCES LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 3, 2023

PANTHER HEALTHCARE Cutter Stapler and Reloading Unit for Cutter Stapler

Manufacturer:

B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 3, 2023

TruWave Disposable Pressure Transducer (DPT) and Pressure Monitoring Kit

Manufacturer:

EDWARDS LIFESCIENCES AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

Edwards VAMP Closed Blood Sampling System

Manufacturer:

EDWARDS LIFESCIENCES AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

AFFACARE Ultrasonic Surgical System

Manufacturer:

AFFACARE MEDICAL (BEIJING) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 21, 2023

ACUMEN IQ Finger Cuff

Manufacturer:

EDWARDS LIFESCIENCES AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2023

I-FIX Abutment or Prosthesis of Dental Implants

Manufacturer:

KAMAL ENCON INDUSTRIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

WISER 3 Diode Laser

Manufacturer:

LAMBDA SPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 28, 2023

WISER 2 Diode Laser

Manufacturer:

LAMBDA SPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 28, 2023

DPLUS Diode Modul for Erbium Laser

Manufacturer:

LAMBDA SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 24, 2023

SIMPLER 2 Diode Laser

Manufacturer:

LAMBDA SPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 22, 2023

PLUSER AND PLUSER KOMBI Erbium Laser

Manufacturer:

LAMBDA SPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 22, 2023

SkinPen + SkinFuse Treatment Kit

Manufacturer:

CROWN AESTHETICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 17, 2023

SkinFuse Lift HG

Manufacturer:

BIOMED LABORATORIES, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2023

SkinPen Precision Microneedling System

Manufacturer:

COGMEDIX

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2023

EVOLIS System

Manufacturer:

STRATEC SE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 2, 2023

EVOLIS Twin Plus

Manufacturer:

STRATEC BIOMEDICAL SWITZERLAND AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2023

Neuropen Monofilaments

Manufacturer:

OWEN MUMFORD SDN BHD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 19, 2023

Neurotips™

Manufacturer:

OWEN MUMFORD SDN BHD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 19, 2023

Neuropen

Manufacturer:

OWEN MUMFORD SDN BHD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 19, 2023

UNISTIK ShieldLock

Manufacturer:

YANGZHOU MEDLINE INDUSTRY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2023

Geenius HCV Supplemental Assay

Manufacturer:

BIO-RAD. (STEENVOORDE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 19, 2023

MONOLISA HBs Ag ULTRA

Manufacturer:

BIO-RAD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 19, 2023

EZITELL hCG Pregnancy Rapid Test Cassette (Urine)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

PROSTEOMAX Calcium Phosphate Bone Cement

Manufacturer:

GRANULAB (M) SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 11, 2023

GRANUMAS Synthetic Bone Graft

Manufacturer:

GRANULAB (M) SDN BHD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 11, 2023

CRAB Vaginal Hyal Gel

Manufacturer:

CRAB SINERGY SRL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2023

UNIFINE Pentips

Manufacturer:

PIKDARE S.R.L,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2023

UNISTIK 3 Extra

Manufacturer:

OWEN MUMFORD SDN BHD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 18, 2023

ENDOFORM™ Natural Restorative Bioscaffold

Manufacturer:

AROA BIOSURGERY LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 17, 2023

DIAMED IH-QC7 Modular System

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2023

MiRXES CoVClear Covid-19 RT-PCR Test

Manufacturer:

MIRXES PTE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2023

DIAMED IH-QC5 Modular System

Manufacturer:

DIAMED GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 15, 2023

DIAMED IH-QC4 Modular System

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 15, 2023

DIAMED IH-QC6 Modular System

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 15, 2023

DIAMED IH-QC8 Modular System

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 15, 2023

DIAMED IH-QC3 Modular System

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 15, 2023

DIAMED IH-QC2 Modular System

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

ID-Diluent 2

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2023

MONOLISA HCV Ag-Ab ULTRA V2

Manufacturer:

BIO-RAD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 22, 2023

ID-Diluent 1

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 9, 2023

ID- Titration Solution

Manufacturer:

DIAMED GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 8, 2023

DENTALMASTER Dental Surgery Drill

Manufacturer:

DENTAL MASTER (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

DENTALMASTER Dental Surgery Instrument

Manufacturer:

DENTAL MASTER (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 7, 2023

DENTALMASTER SLA Dental Implant System

Manufacturer:

DENTAL MASTER (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 2, 2023

BIO-RAD PW40 Microplate Washer

Manufacturer:

BIO-RAD LABORATORIES (SINGAPORE) PTE. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 2, 2023

DENTALMASTER SLA Dental Implant System (Abutment)

Manufacturer:

DENTAL MASTER (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 2, 2023

INNO-LIA Syphilis Score

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 2, 2023

GEENIUS™ Reader and Accessories

Manufacturer:

BIO-RAD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 26, 2023

ID-Antigen Profile III

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

Geenius™ HIV 1/2 Confirmatory Controls

Manufacturer:

BIO-RAD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

DiaClon ABD-Confirmation for Patients

Manufacturer:

DIAMED GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

SAXO ID-Reader II

Manufacturer:

BIO-RAD LABORATORIES (SINGAPORE) PTE. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

DIAMED Coombs Anti-IgG

Manufacturer:

DIAMED GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

ID-DiaClon Anti-D

Manufacturer:

DIAMED GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

DIAMED IH-QC1 Modular System

Manufacturer:

DIAMED GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

BIO-RAD PR 4100 Microplate Reader

Manufacturer:

TECAN AUSTRIA GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

Geenius™ HCV Supplemental Controls

Manufacturer:

BIO-RAD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

DiaClon ABO/D + Reverse Grouping for Donors

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

DiaClon ABD-Confirmation for Donors

Manufacturer:

DIAMED GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

DiaClon Rh-Subgroups + K

Manufacturer:

DIAMED GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

BIO-RAD IH-1000 and Accessories

Manufacturer:

BIO-RAD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

DC-Screening II

Manufacturer:

DIAMED GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

BIO-RAD IH-500 and Accessories

Manufacturer:

BIO-RAD LABORATORIES (SINGAPORE) PTE. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 1, 2023

DIAMED NaCl, Enzyme Test and Cold Agglutinins

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 30, 2022

BIO-RAD Syphilis Total Ab

Manufacturer:

BIO-RAD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2022

ID - Antigen Profile I

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2022

SCHOLLY Light Guide and Adapter

Manufacturer:

SCHOLLY FIBEROPTIC GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 23, 2022

ID-Incubator L and Accessories

Manufacturer:

BIO-RAD LABORATORIES (SINGAPORE) PTE. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 19, 2022

ID-DiaCell I-II

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 10, 2022

DiaClon ABO/D + Reverse Grouping

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 9, 2022

DIAMED ID-DiaCell Pool

Manufacturer:

DIAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2022

DIAMED Wash Solution A Concentrate

Manufacturer:

DIAMED GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 30, 2022

DIAMED ID-Centrifuge L and Accessories

Manufacturer:

BIO-RAD LABORATORIES (SINGAPORE) PTE. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2022

HUGEMED Flexible Video Ureterorenoscope

Manufacturer:

SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2022

HUGEMED Flexible Video Ureterorenoscope

Manufacturer:

SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2022

HUGEMED Flexible Video Ureterorenoscope

Manufacturer:

SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2022

PANTHER HEALTHCARE Linear Cutter Stapler and Reloading Unit for Linear Cutter Stapler

Manufacturer:

B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 10, 2022

PANTHER HEALTHCARE Endo Linear Cutter Stapler and Reloading Unit for Endo Linear Cutter Stapler

Manufacturer:

B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2022

QXDx BCR-ABL %IS Kit

Manufacturer:

BIO-RAD LABORATORIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 29, 2022

SCHÖLLY Laparoscopes

Manufacturer:

SCHOLLY FIBEROPTIC GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 8, 2022

SCHÖLLY Cystoscopes

Manufacturer:

SCHOLLY FIBEROPTIC GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2022

CFX Opus 96 Dx with CFX Maestro Dx SE Software

Manufacturer:

BIO-RAD LABORATORIES (SINGAPORE) PTE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2022

EVEROSHINE Everolimus Eluting Coronary Stent System

Manufacturer:

KAMAL ENCON INDUSTRIES LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 22, 2022

STENOFLEX Sirolimus Eluting Coronary Stent System

Manufacturer:

KAMAL ENCON INDUSTRIES LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 22, 2022

INNOLCON Ultrasonic Surgical System

Manufacturer:

INNOLCON MEDICAL TECHNOLOGY (SUZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 18, 2022

BLOOD Panty Pads 50cm (M-L)

Manufacturer:

QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 21, 2022

BLOOD Panty Pads 50cm (S-M)

Manufacturer:

QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 21, 2022

BLOOD Sanitary Pads 15 cm (Liner)

Manufacturer:

QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 20, 2022

BLOOD Sanitary Pads 29 cm

Manufacturer:

QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 20, 2022

BLOOD Sanitary Pads 25 cm

Manufacturer:

QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 20, 2022

BLOOD Sanitary Pads 33 cm

Manufacturer:

QUANZHOU HUIFENG SANITARY ARTICLES CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 20, 2022

SKYFLOW Thrombectomy Device

Manufacturer:

SKYNOR MEDICAL (SHANGHAI) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 10, 2022

TIMEWAVER

Manufacturer:

TIMEWAVER PRODUCTION GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 3, 2021

TIMEWAVER Frequency

Manufacturer:

TIMEWAVER PRODUCTION GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 3, 2021

FOCUS & FUSION Ultrasound Diagnostic System

Manufacturer:

FOCUS & FUSION HEALTHCARE (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2021

FOCUS & FUSION Ultrasound Diagnostic System

Manufacturer:

FOCUS & FUSION HEALTHCARE (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2021

HEALY

Manufacturer:

HEALY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2021

ENDOFORM Antimicrobial Dermal Template

Manufacturer:

AROA BIOSURGERY LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 20, 2020

ENDOFORM Natural Dermal Template

Manufacturer:

AROA BIOSURGERY LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 20, 2020

BJ-KMC Shaver System

Manufacturer:

SHANGHAI BJ-KMC MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2020

LnK Spinal Instrument System - Surgical Drill Handpiece

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 6, 2019

LnK Spinal Instrument System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 6, 2019

MEDIT Intraoral Scanner i500

Manufacturer:

MEDIT CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2019

HANALYTICS BioMind Diagnostic Support Software

Manufacturer:

HANALYTICS PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 5, 2019

PSLOVE MenstruHeat

Manufacturer:

TAIZHOU BRANCH OF SHANGHAI YINGDU INDUSTRY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 1, 2019

INVENTIS Portable Audiometer Piccolo Speech Aero

Manufacturer:

INVENTIS S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2019

INVENTIS Piccolo Plus

Manufacturer:

INVENTIS S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2019

INVENTIS Portable Audiometer Piccolo Basic Aero

Manufacturer:

INVENTIS S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2019

INVENTIS Middle Ear Analyzer

Manufacturer:

INVENTIS S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2019

INVENTIS Middle Ear Analyzer Clarinet Basic

Manufacturer:

INVENTIS S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2019

INVENTIS Middle Ear Analyzer Audiometer

Manufacturer:

INVENTIS S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2019

INVENTIS Portable Audiometer

Manufacturer:

INVENTIS S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2019

INVENTIS Flute HF

Manufacturer:

INVENTIS S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2019

INNO-LiPA Mycobacteria v2 Amp <20T, CE>

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 16, 2019

INNO-LiPA Mycobacteria v2 <20T, CE>

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 16, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 27, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 27, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 26, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 26, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 26, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 22, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 22, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 22, 2019

PATHLOC-LC Lateral Cage System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2019

PATHLOC-L MIS Spinal System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2019

PATHLOC-LC Lateral Cage System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2019

OPEN LOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2019

PATHLOC-LC Lateral Cage System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2019

CASTLELOC-S Posterior Cervical Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 15, 2019

PATHLOC-L MIS Spinal System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 15, 2019

LnK Lumbar Interbody Fusion Cage System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 15, 2019

CASTLELOC-P Anterior Cervical Plate System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 15, 2019

OPENLOC-L Spinal Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 15, 2019

PATHLOC-L MIS Spinal System, MIS Screw

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2019

CASTLELOC-C Cervical Interbody Fusion Cage System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2019

CASTLELOC-S Posterior Cervical Fixation System

Manufacturer:

L&K BIOMED CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2019

Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.

Last updated: December 2025