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PT. NUGRA KARSERA

Authorized Representative in Indonesia

Rukan Graha Mas Pemuda, Jalan Pemuda Blok AA/ 10
122 Products Represented
31 Manufacturers
Total Products
122
Manufacturers
31
Product Classes
2
Risk Classes
3
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : B
49 products
40.2%
Kelas Resiko : C
43 products
35.2%
Kelas Resiko : D
30 products
24.6%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (122)
Complete portfolio registered with BPOM

TACTIFLEX ™ Sensor Enabled ™ Ablation Catheter

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2025

TACTIFLEX™ Sensor Enabled™ Ablation Catheter

Manufacturer:

ABBOTT MEDICAL COSTA RICA LTDA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2025

AXS Universal Aspiration Tubing

Manufacturer:

MEDELA AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 22, 2025

TactiSys ™ Quartz Equipment

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 2, 2025

NUGRA Hydrophilic Guide Wire

Manufacturer:

LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 10, 2024

ADVISOR ™ VL Circular Mapping Catheter, Sensor Enabled ™

Manufacturer:

ABBOTT MEDICAL COSTA RICA LTDA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 6, 2024

Z-MED ™ Percutaneous Transluminal Valvulopasty Catheter

Manufacturer:

NUMED INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 11, 2024

NUGRA Manifold

Manufacturer:

LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2024

NUGRA High Pressure Extension Tubing

Manufacturer:

LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 23, 2024

NUGRA Angiographic Catheter

Manufacturer:

LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2024

NUGRA Introducer Sheath Sets

Manufacturer:

BRUN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2024

NUGRA Introducer Needle

Manufacturer:

BRUN MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2024

NUGRA Y Connector Set

Manufacturer:

BRUN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

NUGRA Guide Wire

Manufacturer:

BRUN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 8, 2024

NUGRA Radial Artery Tourniquet

Manufacturer:

BRUN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

NUGRA Balloon Inflation Device

Manufacturer:

BRUN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 7, 2024

FlexAbility ™ Sensor Enabled ™ Ablation Catheter

Manufacturer:

ABBOTT MEDICAL COSTA RICA LTDA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 19, 2024

FLEXABILITY™ Ablation Catheter

Manufacturer:

ABBOTT MEDICAL COSTA RICA LTDA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2024

BEYOND Venous Self-Expanding Stent System

Manufacturer:

BENTLEY INNOMED GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 6, 2024

SAFIRE ™ Bi-directional Ablation Catheter

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 12, 2024

INQUIRY ™ Steerable Diagnostic Catheter

Manufacturer:

ABBOTT MEDICAL COSTA RICA LTDA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

AXS INFINITY LS Plus Long Sheath

Manufacturer:

INNEUROCO, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 10, 2024

ADVISOR™ HD Grid Mapping Catheter, Sensor Enabled ™

Manufacturer:

ABBOTT MEDICAL COSTA RICA LTDA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

ADVISOR ™ HD Grid Mapping Catheter, Sensor Enabled ™

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

AXS Catalyst™ Distal Access Catheter

Manufacturer:

STRYKER NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 18, 2024

Excelsior 1018 Reinforced Microcatheter

Manufacturer:

STRYKER NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 13, 2024

SUPREME™ Electrophysiology Catheter

Manufacturer:

ABBOTT MEDICAL COSTA RICA LTDA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 11, 2024

Excelsior SL-10 Microcatheter

Manufacturer:

STRYKER NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 10, 2024

AMPLATZER™ Amulet ™ Left Atrial Appendage Occluder

Manufacturer:

ST JUDE MEDICAL COSTA RICA LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 7, 2024

AMPLATZER™ Amulet ™ Left Atrial Appendage Occluder

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 7, 2024

AXS Vecta Intermediate Catheter

Manufacturer:

INNEUROCO, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 6, 2024

EnSite Velocity ™ Cardiac Mapping System

Manufacturer:

ST. JUDE MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2024

RESPONSE™ Electrophysiology Catheter

Manufacturer:

ABBOTT MEDICAL COSTA RICA LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 6, 2024

AMPLATZER™ Duct Occluder II

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 30, 2024

AMPLATZER ™ Septal Occluder

Manufacturer:

ST JUDE MEDICAL COSTA RICA LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 30, 2024

AMPLATZER™ Duct Occluder

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 30, 2024

AMPLATZER™ P.I. Muscular VSD Occluder

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 21, 2024

AMPLATZER Small™ Occluder

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 21, 2024

AMPLATZER™ Septal Occluder

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 21, 2024

AMPLATZER™ Muscular VSD Occluder

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 21, 2024

Synchro SELECT™ Guidewire

Manufacturer:

STRYKER NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

AMPERE Generator

Manufacturer:

ST. JUDE MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 6, 2024

TARGET Detachable Coil

Manufacturer:

STRYKER NEUROVASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 6, 2024

WORKMATE CLARIS ™ System Display Plus

Manufacturer:

ST. JUDE MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 2, 2024

LIVEWIRE™ Steerable Electrophysiology Catheter

Manufacturer:

ST. JUDE MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 30, 2024

SURPASS EVOLVE™ Flow Diverter System

Manufacturer:

STRYKER NEUROVASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 29, 2024

ADVISOR ™ FL Circular Mapping Catheter, Sensor Enabled™

Manufacturer:

ABBOTT MEDICAL COSTA RICA LTDA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 20, 2024

GATEWAY™ Over-The-Wire PTA Balloon Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 14, 2024

WINGSPAN™ Stent System

Manufacturer:

STRYKER NEUROVASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 6, 2024

INZONE Detachment System

Manufacturer:

BENCHMARK ELECTRONICS, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 1, 2024

TRANSFORM™ Occlusion Balloon Catheter

Manufacturer:

STRYKER NEUROVASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 1, 2024

Trevo XP ProVue Retriever

Manufacturer:

STRYKER NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 22, 2024

TRANSEND™ Guidewire with ICE ™ Hydrophilic Coating

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 21, 2024

Fast-Cath ™ Transseptal Guiding Introducer

Manufacturer:

ABBOTT MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 13, 2024

FAST-CATH ™ Guiding Introducer

Manufacturer:

ABBOTT MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 12, 2024

AMPLATZER™ Amulet ™ Delivery Sheath

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2023

TITA JET™ Light Low Profile Contrast

Manufacturer:

PFM MEDICAL CPP SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 17, 2023

BULB TRANS STAR Embryo Transfer Catheter Bulb Tip

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2023

ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 16, 2023

ACE Single Lumen Ovum Pickup Needle

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 16, 2023

ALLWIN CURVED Intra Uterine Insemination Catheter

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2023

BULB TRANS ULTRA Embryo Transfer Catheter - Bulb Tip

Manufacturer:

ALLWIN MEDICAL DEVICES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2023

ALLWIN Stylet with outer sheath for Embryo Trans / Echo Trans / Twinkle Embryo Trans Catheter

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2023

INSEMINA Intra Uterine Insemination Catheter

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2023

ACE-M Manual Single Lumen Ovum Pickup Needle

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2023

ALLWIN Stylet for FLEXI IUI Intra Uterine Insemination Catheter

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2023

ALLWIN MEDICAL Stylet for Embryo Trans/ Echo Trans/ Twinkle Embryo Trans Catheter

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2023

ALLWIN Stylet for Bulb Trans Ultra / Bulb Trans Star Embryo Transfer Catheter - Bulb Tip

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2023

BRK ™ Transseptal Needle

Manufacturer:

ABBOTT MEDICAL COSTA RICA LTDA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

ALLWIN ECHO TRANS Embryo Transfer Catheter

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

EMBRYO TRANS Embryo Transfer Catheter

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2023

PRO ECHO TRANS Embryo Transfer Catheter

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2023

Jet Port Plus Low Profile

Manufacturer:

PFM MEDICAL CPP SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

JET PORT Plus

Manufacturer:

PFM MEDICAL CPP SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

TITA JET™ Light II Contrast

Manufacturer:

PFM MEDICAL CPP SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 5, 2023

NUGRA Peelable Introducer Set

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2023

NUGRA Stopcock

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2023

NUGRA Pressure Bandage

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

NUGRA Manifolds

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 17, 2023

NUGRA Disposable Pressure Transducers

Manufacturer:

SCW MEDICATH LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2023

NUGRA Hemostasis Valve Set

Manufacturer:

SCW MEDICATH LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2023

NUGRA Introducer Set

Manufacturer:

SCW MEDICATH LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2023

NUGRA Guide Wire

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 1, 2023

NUGRA Connecting Tubing

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 1, 2023

NUGRA Balloon Inflation Devices

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 1, 2023

NUGRA Angiographic Catheter

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 27, 2023

NUGRA Guide Wire

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 26, 2023

BEGRAFT Coronary Stent Graft System

Manufacturer:

BENTLEY INNOMED GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 25, 2023

Ensite X EP System

Manufacturer:

Abbott Medical

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 22, 2023

EnSite X EP System Surface Electrode Kit

Manufacturer:

ABBOTT MEDICAL COSTA RICA LTDA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

SURESTRIP - Vitrification Straws - Weighted

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2023

SURESTRIP - Vitrification Straws

Manufacturer:

ALLWIN MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2023

TYSHAK Mini Pediatric Valvuloplasty Catheter

Manufacturer:

NUMED CANADA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 20, 2022

Z-5 Atrioseptostomy Catheter

Manufacturer:

NUMED CANADA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2022

Amplatzer™ Talisman™

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 16, 2022

Cardea SOLO ™

Manufacturer:

CARDIAC INSIGHT INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2022

TACTICATH ™ Contact Force Ablation Catheter, Sensor Enabled ™

Manufacturer:

ABBOTT MEDICAL COSTA RICA LTDA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 5, 2022

TYSHAK Percutaneous Transluminal Valvuloplasty Catheter

Manufacturer:

NUMED CANADA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2021

Z-MED Percutaneous Transluminal Valvulopasty Catheter

Manufacturer:

NUMED CANADA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2021

Z-MED II Percutaneous Transluminal Valvuloplasty Catheter

Manufacturer:

NUMED CANADA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2021

TYSHAK II Percutaneous Transluminal Valvuloplasty Catheter

Manufacturer:

NUMED CANADA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2021

NUCLEUS Percutaneous Transluminal Valvuloplasty Catheter

Manufacturer:

NUMED CANADA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2021

Agilis ™ EPI Steerable Introducer

Manufacturer:

ST. JUDE MEDICAL COSTA RICA LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2021

CLARIVEIN Infusion Catheter

Manufacturer:

MERIT MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 25, 2021

AIGUILLE Needle for Amniocordocentesis

Manufacturer:

C.C.D. SAS LABORATORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 16, 2021

FRYDMAN Classic

Manufacturer:

LABORATOIRE CCD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2021

CCD SET TDT

Manufacturer:

LABORATOIRE CCD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2021

Insemination Cannula

Manufacturer:

C.C.D. SAS LABORATORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 4, 2021

INQUIRY™ AFocusII™ Diagnostic Catheter

Manufacturer:

IRVINE BIOMEDICAL, INC A ST. JUDE MEDICAL COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 30, 2020

SWARTZ ™ Braided Transseptal Guiding Introducer

Manufacturer:

ST. JUDE MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2020

LIVEWIRE™ TC Ablation Catheter

Manufacturer:

ST. JUDE MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 15, 2020

THERAPY™ Ablation Catheter

Manufacturer:

IRVINE BIOMEDICAL, INC A ST. JUDE MEDICAL COMPANY

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 15, 2020

AMPLATZER ™ TORQVUE ™ LP Catheter

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 25, 2020

Pearl Tip Classic

Manufacturer:

LABORATOIRE CCD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2020

Pearl Tip Soft

Manufacturer:

LABORATOIRE CCD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2020

LABORATOIRE Full Echo Pro

Manufacturer:

LABORATOIRE CCD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2020

Seren AND

Manufacturer:

LABORATOIRE CCD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 2, 2020

AMPLATZER™ PFO Occluder

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 22, 2020

AMPLATZER™ Multifenestrated Septal Occluder

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 13, 2020

AMPLATZER™ Cardiac Plug

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 6, 2020

AMPLATZER ™ TorqVue ™ 45 ° x 45 ° Delivery Sheath

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2020

AMPLATZER™ Sizing Balloon II

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 9, 2019

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

Last updated: December 2025