PRIMUM Hydrophilic Guiding Catheter - Indonesia BPOM Medical Device Registration
PRIMUM Hydrophilic Guiding Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501220457. The device is manufactured by PENDRACARE INTERNATIONAL B.V. from Netherlands, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. STAR OF SUCCESS AWARD.
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
PENDRACARE INTERNATIONAL B.V.Country of Origin
Netherlands
Authorized Representative
PT. STAR OF SUCCESS AWARDAR Address
JL. CILEDUG RAYA RUKO UBUD VILLAGE BLOK KUTA A NO.25, CILEDUG KOTA TANGERANG
Registration Date
Oct 20, 2022
Expiry Date
Aug 01, 2027
Product Type
Diagnostic Cardiology Equipment
Catheter guide wire.
Non Electromedic Sterile
XLIMUS Sirolimus Eluting Coronary Stent System
CARDIONOVUM GMBH
RESTORE DEB Paclitaxel Releasing PTCA Ballon Catheter
CARDIONOVUM GMBH
LEGFLOW Paclitaxel Eluting Perhiperal Balloon Dilatation Catheter
CARDIONOVUM GMBH
EVEREST PTCA Dilatation Catheter
BLUE MEDICAL DEVICES B.V.
SUMMIT CTO Dilatation Catheter
BLUE MEDICAL DEVICES B.V.
FORCE NC PTCA Dilatation Catheter High-Pressure NON-COMPLIANT
BLUE MEDICAL DEVICES B.V.