SIMPASS ENDO .035'' OTW PTA Balloon Dilation Catheter - Indonesia BPOM Medical Device Registration
SIMPASS ENDO .035'' OTW PTA Balloon Dilation Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501911683. The device is manufactured by SIMEKS TIBBI URUNLERI SANAYI V TICARET LIMITED SIRKETI from Turkey, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. WIKATON MITRA TAMA.
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
Country of Origin
Turkey
Authorized Representative
PT. WIKATON MITRA TAMAAR Address
GEDUNG TRIO,JL MAMPANG PRAPATAN RAYA NO.17 RT 004/006, KEL MAMPANG PRAPATAN KEC MAMPANG PRAPATAN
Registration Date
Jan 30, 2023
Expiry Date
Sep 01, 2025
Product Type
Diagnostic Cardiology Equipment
Percutaneous catheter.
Non Electromedic Sterile
ALVEO HP Balloon Dilatation Catheter
BROSMED MEDICAL CO., LTD.
LIMUS TRACK Sirolimus Eluting Cobalt Chromium Coronary Stent System
L2MTECH GMBH
BROSMED POT PTCA Balloon Dilatation Catheter
BROSMED MEDICAL CO., LTD.
SUPRAFLEX CROSS
SAHAJANAND MEDICAL TECHNOLOGIES PVT. LTD.
PIPIT NC PTCA Balloon Dilatation Catheter
SAHAJANNAND MEDICAL TECHNOLOGIES LTD.
PIPIT SC PTCA Balloon Dilation Catheter
SAHAJANNAND MEDICAL TECHNOLOGIES LTD.
COCOON VSD Occluder
VASCULAR INOVATIONS CO.,LTD.
SUPRAFLEX STAR Sirolimus Eluting Cobalt Chromium Coronary Stent System
SAHAJANAND MEDICAL TECHNOLOGIES PVT. LTD.
COCOON PFO Occluder
VASCULAR INOVATIONS CO., LTD.
COCOON Septal Occluder
VASCULAR INOVATIONS CO.,LTD.

