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PT. BOSTON SCIENTIFIC INDONESIA

Authorized Representative in Indonesia

PRUDENTIAL TOWER, LT. 28, JL. JEND. SUDIRMAN KAV. 79
195 Products Represented
40 Manufacturers
Total Products
195
Manufacturers
40
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
1 products
0.5%
Kelas Resiko : B
63 products
32.3%
Kelas Resiko : C
109 products
55.9%
Kelas Resiko : D
22 products
11.3%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (195)
Complete portfolio registered with BPOM

ANGIOJET™ Solent Omni Over-The-Wire Thrombectomy Set

Manufacturer:

BOSTON SCIENTIFIC PUERTO RICO LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 6, 2025

EXTRACTOR PRO Retrieval Ballon Catheter

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 4, 2025

ANGIOJET™ Ultra 5000A Console

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 30, 2025

WALLFLEX Esophageal Partially Covered Stent System

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 30, 2025

ANGIOJET Solent Dista Over-The-Wire Thrombectomy Set

Manufacturer:

BOSTON SCIENTIFIC PUERTO RICO LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 30, 2025

ANGIOJET Solent Proxi Over-The-Wire Thrombectomy Set

Manufacturer:

BOSTON SCIENTIFIC PUERTO RICO LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 30, 2025

ANGIOJET ZelanteDVT Over-The-Wire Thrombectomy Set

Manufacturer:

BOSTON SCIENTIFIC PUERTO RICO LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 26, 2025

WALLFLEX Esophageal Stent System, Fully Covered

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 22, 2025

CAPTIVATOR Single-Use Polypectomy Snare

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 22, 2025

INTELLANAV StablePoint Ablation Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 4, 2025

RANGER OVER-THE-WIRE Paclitaxel-Coated PTA Balloon Catheter

Manufacturer:

HEMOTEQ AT

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 23, 2024

RADIAL JAW 4 Single-Use Standard Capacity Biopsy Forceps

Manufacturer:

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN. BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 6, 2024

AGENT MONORAIL Paclitaxel-Coated PTCA Balloon Catheter

Manufacturer:

HEMOTEQ AT

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 3, 2024

WOLVERINE Coronary Cutting Balloon Monorail Microsurgical Dilatation Device

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 11, 2024

LITHOVUE Single-Use Digital Flexible Ureteroscope

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2024

LithoVue System Workstation

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2024

OPTICROSS 40 MHz Coronary Imaging Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2024

OPTICROSS™ HD 60 MHz Coronary Imaging Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2024

HEDGEHOG Cleaning Brushes

Manufacturer:

CHANGZHOU TEMEIRUI MEDICAL PRODUCTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 22, 2024

UROLOK II Adaptor

Manufacturer:

B. BRAUN OF DOMINICAN REPUBLIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2024

FARAWAVE Pulsed Field Ablation Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION, HEREDIA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 4, 2024

iLab™ Polaris Multi-Modality Guidance System

Manufacturer:

JABIL CIRCUIT (SHANGHAI) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2024

ACURATE neo2 Aortic Valve

Manufacturer:

ACURATE INDUSTRIA E COMERCIO LTDA BHM SITE (BELO HORIZONTE SITE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 29, 2024

LithoVue Empower™ Retrieval Deployment Device

Manufacturer:

NOLATO CONTOUR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

EXPECT Endoscopic Ultrasound Aspiration Needle

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2024

RIGIFLEX II Single Use Achalasia Balloon Dilator

Manufacturer:

CREGANNA MEDICAL S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2024

OPTICROSS 18 30MHz Peripheral Imaging Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 21, 2024

SENTINEL Cerebral Protection System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

WATCHMAN TruSeal Access System

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

AVVIGO+ Multi-Modality Guidance System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION, ST. PAUL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 2, 2024

STARTER Guidewire

Manufacturer:

LAKE REGION MEDICAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 29, 2024

MAVERICK2™ Monorail™ PTCA Dilatation Catheter

Manufacturer:

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN. BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 24, 2024

WALLFLEX Biliary Stent System

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 16, 2024

MACH1 Guide Catheter

Manufacturer:

AVAILMED S.A. DE C.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 11, 2024

MAESTRO 4000 Cardiac Ablation System

Manufacturer:

STELLARTECH RESEARCH CORPORATION.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 5, 2024

Autolith Touch Bipolar Electrohydraulic Lithotripter

Manufacturer:

NORTHGATE TECHNOLOGIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2023

ICEfx Cryoablation System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION, ST. PAUL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 16, 2023

ESCAPE Nitinol Stone Retrieval Basket

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2023

ROTAWIRE Drive and wireClip Torquer Guidewire and Guidewire Manipulation Device

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 10, 2023

ACCUSTICK II Introducer System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2023

G4™ Radiofrequency Generator Kit

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 5, 2023

BOSTON SCIENTIFIC Single Action Pumping System Continuous Flow

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 2, 2023

ICEfx Cryoablation System

Manufacturer:

GALIL MEDICAL, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 2, 2023

ORBITER PV Diagnostic Mapping Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 26, 2023

STERLING™ SL Over-The-Wire PTA Balloon Dilatation Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION (MAPLE GROVE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 2, 2023

WATCHMAN FLX ™ Left Atrial Appendage Closure Device with Delivery System

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 1, 2023

ENDOVIVE Gastronomy Tube with EnFit Connector

Manufacturer:

XERIDIEM MEDICAL DEVICES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 30, 2023

UROVAC Bladder Evacuator

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

BOSTON Malecot Nephrostomy Catheter Set

Manufacturer:

BOSTON SCIENTIFIC CORPORATION, Spencer

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2023

SAMURAI RC Guidewire

Manufacturer:

FMD CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 30, 2022

ZERO TIP Nitinol Stone Retrieval Basket

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2022

AURIGA XL 4007 Laser System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 30, 2022

ENDOVIVE Standard PEG Kits with ENFit

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2022

BOSTON SCIENTIFIC Ureteral Dilatation System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2022

STINGRAY Guidewire with Hydrophilic Coating

Manufacturer:

LAKE REGION MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 26, 2022

INTELLA MAP Orion High Resolution Mapping Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 26, 2022

WALLFLEX Duodenal Stent System with Anchor Lock Delivery System

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 23, 2022

SYNERGY Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 22, 2022

SENSATION Short Throw Medium Stiff Single-Use Polypectomy Snare

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 21, 2022

SENSATION Short Throw Single-Use Polypectomy Snare

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 21, 2022

HYDRA JAGWIRE High Performance Guidewire

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 21, 2022

FLEXIMA Biliary Catheter System Kit

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2022

BOSTON SCIENTIFIC Percutaneous Access Needle with Echogenic Tip

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

BOSTON SCIENTIFIC Amplatz Type Graduated Renal Dilatation Set

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

CONTOUR Ureteral Stent

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2022

ANGIOJET PE OVER-THE-WIRE Thrombectomy Set

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 16, 2022

ANGIOJET AVX OVER-THE-WIRE Thrombectomy Set

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 16, 2022

BOSTON SCIENTIFIC Dual Lumen Ureteral Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 16, 2022

VICTORY 18 Polymer Tip Guidewire with Hydrophilic Coating

Manufacturer:

LAKE REGION MEDICAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2022

WATCHMAN Left Atrial Appendage Closure Device with Delivery System

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 14, 2022

ZERO TIP Airway Retrieval Basket

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

TRAPEZOID RX Wire-guided Retrieval Basket

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

ZEBRA Guidewire

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2022

ANGIOJET Ultra Console

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2022

VIKING Fixed Curve Diagnostic Electrode Catheters

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2022

Resolution 360™ Clip

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2022

THRUWAY Guidewire

Manufacturer:

LAKE REGION MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2022

STERLING™ Over-the-Wire PTA Balloon Dilatation Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2022

RADIAL JAW 4 Pediatric Single-Use Biopsy Forceps

Manufacturer:

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2022

V-14 ControlWire Guidewire with ICE Hydrophilic Coating

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2022

UROLOK II Adaptor

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2022

TRANSEND Guidewire with ICE Hydrophilic Coating

Manufacturer:

BOSTON SCIENTIIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2022

V-18 Control Wire Guidewire with ICE Hydrophilic Coating

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2022

ROTABLATOR Rotational Atherectomy System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2022

DC BEAD M1™ Embolic Drug-Eluting Bead

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 10, 2022

SAMURAI Guidewire

Manufacturer:

FMD CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 3, 2022

STONE CONE Nitinol Urological Retrieval Coil

Manufacturer:

VENUSA DE MEXICO, S.DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2022

SPYBITE Single-Use Biopsy Forceps

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2022

STINGRAY LP Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 2, 2022

RADIAL JAW 4 Single-Use Standard Capacity Biopsy Forceps

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2022

RUBICON 14 Support Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 28, 2022

RADIAL JAW 4 Single-Use Pulmonary Biopsy Forceps

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 26, 2022

SENSOR Nitinol Wire With Hydrophilic Tip

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 21, 2022

MACH1 Peripheral Guide Catheter

Manufacturer:

AVAILMED S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 21, 2022

JUDO™ 6 Guidewire

Manufacturer:

FMD CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2022

JUDO™ 3 Guidewire

Manufacturer:

FMD CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2022

JUDO™ 1 Guidewire

Manufacturer:

FMD CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2022

REZUM Delivery Device Kit

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 11, 2022

RUNWAY Guide Catheter

Manufacturer:

AVAILMED S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 8, 2022

SUMMARY Generator

Manufacturer:

NORTECH SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 4, 2022

RADIAL JAW 4 Single-Use Large Capacity Biopsy Forceps

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2022

RADIAL JAW 4 Hot Single-Use Biopsy Forceps

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2022

RADIAL JAW 4 Jumbo Single-Use Biopsy Forceps

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2022

POLARIS Ultra Ureteral Stent

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 21, 2022

LIGHTTRAIL Single Use Laser Fibers

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 21, 2022

OCCLUDER Occlusion Ballon Catheter

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 16, 2022

NEPHROMAX High Pressure Nephrostomy Balloon Catheter

Manufacturer:

BOSTON SCIENTIFIC LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2022

POLARIS Loop Ureteral Stent

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 8, 2022

NAVIGATOR HD Ureteral Access Sheath Set

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 4, 2022

PERCUFLEX Plus Ureteral Stent

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 1, 2022

NAVIFLEX Rapid Exchange (RX) Pancreatic Delivery System and Pushers

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 1, 2022

NAVIFLEX RX Delivery System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 1, 2022

INNOVA Over-The-Wire Self-Expanding Stent System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 30, 2022

FLEXIMA APDL Drainage Catheter System Kit

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 16, 2022

IMAGER II Urology Torque Catheter

Manufacturer:

TELEFLEX MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 11, 2022

INTERJECT Contrast Injection Therapy Needle Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2022

JETSTREAM SC OVER-THE-WIRE Atherectomy Catheter

Manufacturer:

BOSTON SCIENTIFIC LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2022

JETSTREAM XC OVER-THE-WIRE Atherectomy Catheter

Manufacturer:

BOSTON SCIENTIFIC LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2022

BOSTON Jagwire High Performance Guidewire

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2022

FLEXIMA Biliary Catheter System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 3, 2022

BOSTON TANDEM XL Triple Lumen ERCP Cannula

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2022

ENDOVIVE Standard PEG Kits

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2022

MICROKNIFE XL Triple Lumen Needle Knife

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2022

CONTOUR ERCP Cannula

Manufacturer:

VENUSA DE MEXICO S de RL de CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2022

EXCELON Transbronchial Aspiration Needle

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2022

EXPRESS LD Vascular Over-The-Wire Premounted Stent System

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 22, 2022

FLEXIMA™ APD Drainage Catheter System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 22, 2022

MARVEL Guidewire

Manufacturer:

FMD CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 22, 2022

FIGHTER Guidewire

Manufacturer:

FMD CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 22, 2022

HORNET 10 Guidewire

Manufacturer:

FMD CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 22, 2022

HORNET 14 Guidewire

Manufacturer:

FMD CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 22, 2022

EXPECT Slimline (SL) Endoscopic Ultrasound Aspiration Needle

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2022

EXPEL Drainage Catheter with Twist-Loc Hub MPDL Drainage Catheter Kit

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 19, 2022

EXPEL Drainage Catheter with Twist-Loc Hub MPDL Drainage Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 19, 2022

ENCORE Advantage Kit Inflation Device

Manufacturer:

BOSTON SCIENTIFIC LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2022

BOSTON SCIENTIFIC Amplatz Type Renal Dilator/ Sheath Set

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2022

COYOTE Over-The-Wire PTA Balloon Dilatation Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 13, 2022

RX Cytology Brush

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2022

BOSTON SCIENTIFIC Percutaneous Access Needle

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 8, 2022

CRE PRO Wireguided Balloon Dilatation Catheter

Manufacturer:

BOSTON SCIENTIFIC LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2022

CELLEBRITY Endoscopic Cytology Brush

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2022

BOSTON SCIENTIFIC Amplatz Type Renal Sheath

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2022

Carotid WALLSTENT Monorail Endoprosthesis

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 27, 2022

BLAZER Open-Irrigated Ablation Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 27, 2022

FLEXIMA™ APDL Drainage Catheter System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 23, 2022

CRE Pulmonary Balloon Dilatation Catheter

Manufacturer:

BOSTON SCIENTIFIC LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

ANGIOJET SOLENT Omni OVER-THE-WIRE Thrombectomy Set

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 21, 2022

ANGIOJET Solent Dista OVER-THE-WIRE Thrombectomy Set

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 21, 2022

BACK-UP Meier Steerable Guidewire

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 18, 2022

FILTERWIRE EZ Embolic Protection System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 18, 2022

ANGIOJET Solent Proxi OVER-THE-WIRE Thrombectomy Set

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 14, 2022

ANGIOJET Ultra Power Pulse Kit

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 10, 2022

ANGIOJET ZELANTEDVT OVER-THE-WIRE Thrombectomy Set

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 9, 2022

AMPLATZ SUPERSTIFF Guidewire

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 8, 2022

AMPLATZ SUPER STIFF Guidewire

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 3, 2022

ALLIANCE II Single-Use Syringe/ Gauge Assembly

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 2, 2022

ADVANIX Biliary Stent

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 28, 2022

ACQUIRE ™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2022

ADVANIX Pancreatic Stent

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 25, 2022

RADIAL JAW 4 Pediatric Single-Use Biopsy Forceps

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2022

2CM PERIPHERAL CUTTING BALLOON Over-The Wire Microsurgical Dilatation Device

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 18, 2022

ALLIANCE II Integrated Inflation / Litho Device

Manufacturer:

VIANT AS&O HOLDINGS, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 18, 2022

WOLVERINE Coronary Cutting Balloon Monorail Microsurgical Dilatation Device

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 13, 2022

TANDEM™ XL Triple Lumen ERCP Cannula

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 12, 2022

CROSSBOSS™ Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 10, 2022

DREAMWIRE High Performance Guidewire

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 28, 2022

EMERGE Push Monorail™ PTCA Dilatation Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2022

CONTOUR Embolization Particles

Manufacturer:

BOSTON SCIENTIFIC LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2022

SPEEDBAND SUPERVIEW SUPER 7 Multiple Band Ligator

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2022

DAKOTA™ Nitinol Stone Retrieval Device with OpenSure™ Handle

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 10, 2022

TRUEtome Cannulating Sphincterotome

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2022

HEDGEHOG Endoscope Cleaning Brushes

Manufacturer:

SUZHOU TEMEIRUI MEDICAL PRODUCTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 14, 2022

POLARSHEATH Steerable Sheath

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2022

BLOX Endoscopic Bite Block with Elastic Cloth Strap

Manufacturer:

JIANGSU JIANYU HEALTH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 13, 2022

POLARMAP Circular Mapping Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 11, 2022

RESCUENET™ Retrieval Device

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2021

RHYTHMIA HDX Mapping System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 25, 2021

RESCUE Grasping Forceps

Manufacturer:

ANREI MEDICAL (HZ) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2021

AMS 800 Artificial Urinary Sphincter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 10, 2021

AURIGA XL 4007 Laser System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 1, 2021

NAVIPRO Hydrophilic Guidewires

Manufacturer:

VENUSA DE MEXICO S. DE R.L DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2021

METRIQ Pump

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 3, 2021

NC EMERGE™ Monorail™ PTCA Dilatation Catheter

Manufacturer:

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN BHD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 27, 2021

SPYBITE™ Max Single-Use Biopsy Forceps

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 27, 2021

AMS 700 Inflatable Penile Prosthesis

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 18, 2021

EMERGE™ MONORAIL™ PTCA Dilatation Catheter

Manufacturer:

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN BHD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 11, 2021

EMERGE™ Push MONORAIL™ PTCA Dilatation Catheter

Manufacturer:

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN BHD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 25, 2021

LIGHTTRAIL™ TRACTIP™ Single Use Holmium Laser Fiber

Manufacturer:

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN BHD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 27, 2021

CAPTIFLEX Single-Use Polypectomy Snare

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 9, 2021

TRUEPATH CTO Device

Manufacturer:

BOSTON SCIENTIFIC LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 19, 2021

MAVERICK2™ Monorail™ PTCA Dilatation Catheter

Manufacturer:

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2020

BOSTON JETSTREAM PVCN100 Console

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2020

INTELLATIP MIFI XP Temperature Ablation Catheter

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 12, 2019

BOSTON SCIENTIFIC Biliary Stent Introducer

Manufacturer:

BOSTON SCIENTIFIC CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 31, 2018

BOSTON ROTABLATOR™ Rotational Angioplasty System

Manufacturer:

BOSTON SCIENTIFIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 31, 2018

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

Last updated: December 2025