SAPPHIRE 3 Coronary Dilatation Catheter - Indonesia BPOM Medical Device Registration
SAPPHIRE 3 Coronary Dilatation Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20505220131. The device is manufactured by ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MAIN REVASS MEDIKA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.Country of Origin
China
Authorized Representative
PT. MAIN REVASS MEDIKAAR Address
Jl. Dewi Sartika No. 4B RT 004/007 Kel. Cililitan Kec. Kramat jati
Registration Date
Nov 29, 2022
Expiry Date
Sep 21, 2027
Product Type
Therapeutic Cardiology Equipment
Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
Non Electromedic Sterile
TELEPORT NEURO Microcatheter
SAPPHIRE Neuro Balloon Dilatation Catheter
SCOREFLEX TRIO Balloon Dilatation Catheter
JADE PTA Balloon Dilatation Catheter
SCOREFLEX NC Coronary Dilatation Catheter
JADE PTA Balloon Dilatation Catheter
SCOREFLEX PTA Balloon Dilatation Catheter
SAPPHIRE II PRO Coronary Dilatation Catheter
TELEPORT Microcatheter
SAPPHIRE NC 24 Coronary Dilatation Catheter
G-CRUISER Interventional Delivery System for Biodegradable Occluder
SHANGHAI SHAPE MEMORY ALLOY CO., LTD.
MEMOSORB Biodegradable Ventricular Septal Defect (VSD) Occluder System
SHANGHAI SHAPE MEMORY ALLOY CO., LTD.
MEMOCARNA Atrial Septal Defect (ASD) Occluder
SHANGHAI SHAPE MEMORY ALLOY CO., LTD.
MEMOPART Ventricular Septal Defect (VSD) Occluder
SHANGHAI SHAPE MEMORY ALLOY CO., LTD.
MEMOPART โข Patent Foramen Ovale (PFO) Occluder
SHANGHAI SHAPE MEMORY ALLOY CO., LTD.
MEMOPART Atrial Septal Defect (ASD) Occluder
SHANGHAI SHAPE MEMORY ALLOY CO., LTD.
MEMOPART Patent Ductus Arteriosus (PDA) Occluder
SHANGHAI SHAPE MEMORY ALLOY CO., LTD.
MEMOPART Snare
SHANGHAI SHAPE MEMORY ALLOY CO., LTD.
MEMOPART Occluder Delivery System
SHANGHAI SHAPE MEMORY ALLOY CO., LTD.
ANGIOWAY Manifold (Right Off)
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.

