Pure Global
Home/Indonesia Database/Authorized Representative
🇮🇩

ENDO INDONESIA

Authorized Representative in Indonesia

Jl. Raya Menganti 14
179 Products Represented
63 Manufacturers
Total Products
179
Manufacturers
63
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
29 products
16.2%
Kelas Resiko : B
101 products
56.4%
Kelas Resiko : C
43 products
24.0%
Kelas Resiko : D
6 products
3.4%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (179)
Complete portfolio registered with BPOM

ENDO Single Use Retrieval Net

Manufacturer:

ANREI MEDICAL (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

ENDO Bite Block

Manufacturer:

ANREI MEDICAL (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

POTENT Holmium Laser Therapeutic Apparatus

Manufacturer:

GUANGZHOU POTENT MEDICAL EQUIPMENT JOINT-STOCK CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 3, 2025

ENDO Disposable Electrosurgical Pencils

Manufacturer:

JINHUA HUACHENG MEDICAL APPLIANCE CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2024

ROMSONS Intrasafe Intravenous Cannula

Manufacturer:

ROMSONS INTERNATIONAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 7, 2024

SEPLOU Percutaneous Nephrostomy Set with Pigtail Catheter

Manufacturer:

BONREE MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2024

TONTARRA Flexible Ureterorenoscope

Manufacturer:

EMOS TECHNOLOGY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2024

ENDO Trauma Implants Instruments

Manufacturer:

SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 4, 2024

TONTARRA Flexible Cystoscope

Manufacturer:

EMOS TECHNOLOGY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

HUONS Automated Endoscope Reprocessor

Manufacturer:

HUONS MEDITECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

POTENT Holmium Laser Therapeutic Apparatus

Manufacturer:

GUANGZHOU POTENT MEDICAL EQUIPMENT JOINT-STOCK CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 24, 2024

INVENTIS Middle Ear Analyzer Flute Plus

Manufacturer:

INVENTIS S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2024

ENDOVISION 3DXT Cage Instruments

Manufacturer:

ENDOVISION CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 21, 2024

ENDOVISION 3DXT Cage

Manufacturer:

ENDOVISION CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 20, 2024

POTENT Holmium Laser Therapeutic Apparatus

Manufacturer:

GUANGZHOU POTENT MEDICAL EQUIPMENT JOINT-STOCK CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 9, 2024

SEPLOU Ureteral Dilator

Manufacturer:

BONREE MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2024

MIR Spirodoc

Manufacturer:

MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

SEPLOU Lscope Single­Use Digital Flexible Ureteroscope

Manufacturer:

BONREE MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

SEPLOU Ureteral Access Sheath

Manufacturer:

BONREE MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

TROPIAN Trocar System

Manufacturer:

ZERONE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 3, 2024

SEPLOU Ureteral Dilation Balloon Catheter

Manufacturer:

BONREE MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 29, 2024

BLUEENDO MOREsolution System

Manufacturer:

TROKAMED GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2024

MIR Spirometer

Manufacturer:

MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 26, 2024

MIR Spirometer

Manufacturer:

MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2024

ENDOVISION Reusable Surgical Instruments

Manufacturer:

ENDOVISION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 20, 2024

ENDO Dilatation and Curettage Set

Manufacturer:

PATWAL SURGICAL CO.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 15, 2024

MED-FIBERS Surgical Laser Fiber

Manufacturer:

MED-FIBERS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 15, 2024

ENDOVISION Medical Fluid Pump

Manufacturer:

VIMEX SP. ZO.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2024

ENDOVISION Flexcat-R Epidural Catheter System

Manufacturer:

ENDOVISION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

ENDOVISION UBE Scope Kit

Manufacturer:

ENDOVISION CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

ENDO Tonsillectomy Instrument Set

Manufacturer:

PATWAL SURGICAL CO.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 28, 2024

ENDO Mastoidectomy Instrument Set

Manufacturer:

PATWAL SURGICAL CO.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 26, 2024

SEPLOU Ureteral Stent Set with Guidewire

Manufacturer:

BONREE MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 26, 2024

ENDOVISION UBE Flex Probe

Manufacturer:

ENDOVISION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 26, 2024

ENDO Mayor Basic Surgery Set

Manufacturer:

PATWAL SURGICAL CO.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 26, 2024

ZKSK Endoscopic Gastrostomy (PEG) Kit

Manufacturer:

BEIJING ZKSK TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 19, 2024

WASTON Disposable Endoscopic Cutter Stapler and Cartridge

Manufacturer:

CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2024

MIR SMART ONE PEAK FLOW and FEVI METER

Manufacturer:

MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2024

SEPLOU Ureteral Stent

Manufacturer:

BONREE MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 31, 2024

SEPLOU Percutaneous Nephrostomy Set

Manufacturer:

BONREE MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 31, 2024

SEPLOU Ureteral Catheter

Manufacturer:

BONREE MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 30, 2024

SEPLOU Zebra Guidewire

Manufacturer:

BONREE MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 22, 2024

ENDO Circumcision Set

Manufacturer:

PATWAL SURGICAL CO.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 17, 2024

SEPLOU Ureteral Access Sheath

Manufacturer:

BONREE MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 12, 2024

ENDO Tubular Bandage

Manufacturer:

YASCO ENTERPRISE CORP

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 11, 2024

TONTARRA Pump

Manufacturer:

W.O.M. WORLD OF MEDICINE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 9, 2024

TONTARRA Insufflator 50L

Manufacturer:

W.O.M. WORLD OF MEDICINE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2024

SONOSCAPE Video System Center

Manufacturer:

SONOSCAPE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2024

SONOSCAPE Light Source

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 3, 2024

SEESHEEN Flexible Video Choledochoscope

Manufacturer:

ZHUHAI SEESHEEN MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2023

WASTON Disposable Three Row PPH Stapler

Manufacturer:

CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 20, 2023

SONOSCAPE Video Duodenoscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2023

TONTARRA Laparoscopy Gynecology Instrument

Manufacturer:

TONTARRA MEDIZINTECHNIK GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2023

WASTON Disposable Three Row Auto Linear Stapler and Cartridge

Manufacturer:

CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

ENDOVISION UBE VISION, Spinuss Sheath

Manufacturer:

ENDOVISION CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2023

WASTON Disposable Endoscopic Cutter Stapler and Cartridge

Manufacturer:

CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2023

WASTON Disposable Three Row Circular Stapler

Manufacturer:

CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2023

WASTON Disposable Linear Cutter and Cartridge

Manufacturer:

CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2023

OTIS Implants for High Tibial Osteotomy

Manufacturer:

S.B.M. SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2023

OTIS Plates and Screws for High Tibial Osteotomy and Femoral Osteotomy

Manufacturer:

S.B.M. SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2023

SEESHEEN Flexible Video Ureterorenoscope

Manufacturer:

ZHUHAI SEESHEEN MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2023

SEESHEEN Flexible Video Choledochoscope

Manufacturer:

ZHUHAI SEESHEEN MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2023

SEESHEEN Flexible Video Rhinolaryngoscope

Manufacturer:

ZHUHAI SEESHEEN MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

SEESHEEN Flexible Video Rhinolaryngoscope

Manufacturer:

ZHUHAI SEESHEEN MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

SEESHEEN Flexible Video Intubation Laryngoscope

Manufacturer:

ZHUHAI SEESHEEN MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

SEESHEEN Flexible Video Bronchoscope

Manufacturer:

ZHUHAI SEESHEEN MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 2, 2023

SONOSCAPE Video Gastroscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2023

EZLIG Multi-Band Ligator

Manufacturer:

BEIJING ZKSK TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2023

SONOSCAPE Video Colonoscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

SONOSCAPE Ultrasonic Gastrovideoscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2023

SEESHEEN Flexible Video Cystonephroscope

Manufacturer:

ZHUHAI SEESHEEN MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2023

ROMSONS Catheter Mount

Manufacturer:

ROMSONS INTERNATIONAL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 17, 2023

SONOSCAPE Light Source

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 16, 2023

ENDO Surgical Table Hydraulic

Manufacturer:

BıÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET ANONIM SIRKETI

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 14, 2023

ENDO Surgical Table Electro Hydraulic

Manufacturer:

BıÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET ANONIM SIRKETI

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 14, 2023

SONOSCAPE Light Source

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2023

SONOSCAPE Image Processor

Manufacturer:

SONOSCAPE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 10, 2023

SONOSCAPE Video Gastroscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2023

SONOSCAPE Video Colonoscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

SONOSCAPE Light Source

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

SONOSCAPE Video Gastroscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2023

SONOSCAPE Video Colonoscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2023

SONOSCAPE Video Colonoscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2023

SONOSCAPE Video Colonoscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2023

SONOSCAPE Video Colonoscope

Manufacturer:

SONOSCAPE MEDICAL CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2023

DUK-IN Lite S

Manufacturer:

DUK-IN CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 26, 2023

DUK-IN S-Splint

Manufacturer:

DUK-IN CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 26, 2023

SONOSCAPE Video Bronchoscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2023

SONOSCAPE Video Bronchoscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2023

SONOSCAPE Video Processor

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2023

KANG JIAN Vacuum Tube (PET / Plastic) Plain

Manufacturer:

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2023

SONOSCAPE Video Bronchoscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2023

SONOSCAPE Video Endoscope System

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2023

KANGJIAN Vacuum Tube EDTA K2

Manufacturer:

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2023

KANGJIAN Vacuum Tube Plain

Manufacturer:

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2023

SONOSCAPE Video Rhinolaryngoscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2023

SONOSCAPE Colonoscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2023

KANG JIAN Vacuum Tube, ESR Tube

Manufacturer:

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2023

KANGJIAN Vacuum Tube Clot Activator

Manufacturer:

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2023

KANGJIAN Vacuum Tube Clot Activator

Manufacturer:

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2023

KANGJIAN Vacuum Tube EDTA K3

Manufacturer:

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2023

KANGJIAN Vacuum Tube EDTA K3

Manufacturer:

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2023

KANGJIAN Vacuum Tube EDTA K3

Manufacturer:

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2023

SONOSCAPE Video Gastroscope

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 14, 2023

LOSPA KNEE SYSTEM INSTRUMENTS

Manufacturer:

CORENTEC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 5, 2023

KANGJIAN Vacuum Tube Gel & Clot Activator

Manufacturer:

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 4, 2023

KANGJIAN Vacuum Tube Gel & Clot Activator

Manufacturer:

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2023

KANGJIAN Vacuum Tube Lithium Heparin

Manufacturer:

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

KANGJIAN Vacuum Tube Sodium Citrate

Manufacturer:

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

GOMINA Saw Blades

Manufacturer:

GUM AG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 25, 2023

MEDIPIA Endoscope Washer & Disinfector

Manufacturer:

MEDIPIA CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2023

KANGJIAN Vacuum Tube Glucose

Manufacturer:

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2023

LOSPA Total Knee Replacement System

Manufacturer:

CORENTEC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 17, 2023

MEDIPIA Endoscope Washer & Disinfector

Manufacturer:

MEDIPIA CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2023

UROCATH 3 Way Foley Catheter

Manufacturer:

ROMSONS INTERNATIONAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2023

LOSPA IS Spinal Cage Instruments

Manufacturer:

CORENTEC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 17, 2023

LOSPA IS Spinal Pedicle Screw

Manufacturer:

CORENTEC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 17, 2023

TRULIFE Oasis Pressure Care

Manufacturer:

TRULIFE

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 16, 2023

TECRES Bone Injection Needle

Manufacturer:

TECRES S.P.A.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 8, 2023

TONTARRA Laparoscopy Urology Instrument

Manufacturer:

TONTARRA MEDIZINTECHNIK GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2023

MENDEC Spine

Manufacturer:

TECRES S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 6, 2023

AYGUN Surgical Motor System

Manufacturer:

AYGUN SURGICAL INSTRUMENTS INDUSTRY AND TRADE CO. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2023

AYGUN Karinca 206 Surgical Motor Systems

Manufacturer:

AYGUN CERRAHI ALETLER SANAYI VE TICARET A.S. / AYGUN SURGICAL INSTRUMENTS CO., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2023

AYGUN High Speed Motor Micro Systems

Manufacturer:

AYGUN SURGICAL INSTRUMENTS INDUSTRY AND TRADE JOINT STOCK COMPANY ( AYGUN SURGICAL INSTRUMENTS CO., INC. )

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 24, 2023

AYGUN Karinca 206 Surgical Motor Systems

Manufacturer:

AYGUN SURGICAL INSTRUMENTS INDUSTRY AND TRADE CO. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2023

AYGUN HSM 2 High Speed Electro Surgical Motor Systems

Manufacturer:

AYGUN SURGICAL INSTRUMENTS INDUSTRY AND TRADE JOINT STOCK COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2023

AYGUN Dermatome ST-5 System

Manufacturer:

AYGUN SURGICAL INSTRUMENTS INDUSTRY AND TRADE JOINT STOCK COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2023

AYGUN Scoren Surgical Power System

Manufacturer:

AYGUN SURGICAL INSTRUMENTS INDUSTRY AND TRADE JOINT STOCK COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 11, 2023

AYGUN Karinca 206 Surgical Motor Systems

Manufacturer:

AYGUN SURGICAL INSTRUMENTS INDUSTRY AND TRADE CO. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 11, 2023

AYGUN Karinca 206 Surgical Motor Systems

Manufacturer:

AYGUN SURGICAL INSTRUMENTS INDUSTRY AND TRADE CO. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 11, 2023

ENDO Rectal Tubes

Manufacturer:

NINGBO MFLAB MEDICAL INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2023

SMARTY SAVER Defibrillator

Manufacturer:

A.M.I. ITALIA S.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 22, 2023

SAVER ONE D Defibrillator

Manufacturer:

A.M.I. ITALIA S.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 22, 2023

SAVER ONE Defibrillator

Manufacturer:

A.M.I. ITALIA S.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 22, 2023

AMPALL Syringe Pump

Manufacturer:

AMPALL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 20, 2023

ASELSAN HEARTLINE AED Defibrillator

Manufacturer:

RITIM GRUP TIBBI CIHAZLAR ELETRONIK SANAYI VE TICARET ANONIM SIRKETI ANKARA BRANCH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 7, 2023

FIXIT Threaded Anchor System

Manufacturer:

S.B.M. SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2023

AMPALL Infusion Pump

Manufacturer:

AMPALL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2023

POWERTEX Non-absorbable surgical suture loaded with needle

Manufacturer:

RIVERPOINT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 6, 2023

SBM PULLUP Adjustable Fixation System for Ligament

Manufacturer:

S.B.M., S.A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 30, 2023

MEDICAL ULTRASOUND GEL

Manufacturer:

SHANGHAI SHENFENG MEDICAL&HEALTH ARTICLES CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2023

MENIX DUO Meniscal suture system, 2 anchors

Manufacturer:

S.B.M. SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2022

ROMSONS Salem Sump Tube

Manufacturer:

ROMSONS INTERNATIONAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2022

ROMSONS Leg Bag

Manufacturer:

ROMSONS INTERNATIONAL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 13, 2022

ROMSONS Hi Mask

Manufacturer:

ROMSONS INTERNATIONAL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 30, 2022

ROMSONS Respirometer

Manufacturer:

ROMSONS INTERNATIONAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2022

ROMSONS Oxy Lock

Manufacturer:

ROMSONS INTERNATIONAL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 30, 2022

ROMSONS SILKO MASK Spare Silicone Mask for Resuscitator

Manufacturer:

ROMSONS INTERNATIONAL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 27, 2022

ROMSONS Infant Feeding Tube

Manufacturer:

ROMSONS INTERNATIONAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

MENIX Instruments

Manufacturer:

S.B.M. SAS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 18, 2022

TRULIFE Breast Care

Manufacturer:

TRULIFE

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 19, 2022

CEMEX Genta ID Green

Manufacturer:

TECRES S.P.A.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 13, 2022

VANCOGENX SPACE Knee

Manufacturer:

TECRES S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 23, 2022

ENDO Knee System : Tibial

Manufacturer:

BEIJING CHUNLIZHENGDA MEDICAL INSTRUMENTS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 18, 2022

ENDO Knee System : Femoral Component

Manufacturer:

BEIJING CHUNLIZHENGDA MEDICAL INSTRUMENTS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 14, 2022

ENDO Hip System : Total Hip Replacement

Manufacturer:

BEIJING CHUNLIZHENGDA MEDICAL INSTRUMENTS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 14, 2022

ROMSONS Suction Catheter

Manufacturer:

ROMSONS INTERNATIONAL (UNIT-II)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2021

OXMED ZenSiv Urostomy Bag

Manufacturer:

OXMED INTERNATIONAL GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 1, 2021

OXMED ZenSiv Ileostomy Bag

Manufacturer:

OXMED INTERNATIONAL GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 30, 2021

APEX DIGIFLOW Uroflometry System

Manufacturer:

APEX MEDITECH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2021

APEX DIGIFLOW Uroflometry System

Manufacturer:

APEX MEDITECH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2021

OXMED ZenSiv Colostomy Bag

Manufacturer:

OXMED INTERNATIONAL GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 17, 2021

ROMSONS Umbilical Catheter

Manufacturer:

ROMSONS INTERNATIONAL (UNIT-II)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 14, 2021

ROMSONS Suction Connecting Tube

Manufacturer:

ROMSONS INTERNATIONAL (UNIT-II)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2021

TELECTRODE Disposable ECG Electrodes

Manufacturer:

BIO PROTECH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2021

ZKSK EASYPULSE ™ Disposable Pulse Wash

Manufacturer:

BEIJING ZKSK TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 17, 2021

LOOPIX Wound Drainage Tube Fixing Tube

Manufacturer:

ZHEJIANG HAICHUANG MEDICAL DEVICE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2021

ENDO Titanium Trauma Implants Screw

Manufacturer:

SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 25, 2021

ENDO Portable Phlegm Suction Pump

Manufacturer:

JIANGSU YUYUE MEDICAL EQUIPMENT&SUPPLY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2021

Accumax Fab Micropipette Fixed Volume

Manufacturer:

ACCUMAX LAB DEVICES PVT. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 23, 2021

Accumax Fab Micropipette Variable Volume

Manufacturer:

ACCUMAX LAB DEVICES PVT. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 23, 2021

SONOSCAPE Light Source

Manufacturer:

SONOSCAPE MEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 29, 2021

YOUSHI Laparoscopic Instruments

Manufacturer:

TONGLU YOUSHI MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 7, 2021

AMPALL Automatic Blood Pressure Monitor

Manufacturer:

AMPALL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2020

Life Point Plus Biphasic Defibrillator with Pace Maker

Manufacturer:

METSIS MEDIKAL TEKNIK SISTEMLER ELEKTRONIK OTOMOTIV İNŞAAT TURİZM VE SANAYİ TİCARET LİMİTED ŞİRKETİ

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 16, 2020

TRAUHUI Spine Posterior Fixation System

Manufacturer:

JIANGSU TRAUHUI MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 6, 2019

TRAUHUI Coales Fusion Cage System

Manufacturer:

JIANGSU TRAUHUI MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2019

TRAUHUI Cervical Plate System

Manufacturer:

JIANGSU TRAUHUI MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2019

CALEB Single Use Pulse Lavage

Manufacturer:

CALEB CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2019

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

Last updated: December 2025