OPTIMA SC Semi Compliant PTCA Balloon Catheter - Indonesia BPOM Medical Device Registration
OPTIMA SC Semi Compliant PTCA Balloon Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501420246. The device is manufactured by TRANSLUMINA THERAPEUTICS LLP from India, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is Dharma Saputra Medica.
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
TRANSLUMINA THERAPEUTICS LLPCountry of Origin
India
Authorized Representative
Dharma Saputra MedicaAR Address
JL. SUMATERA NO. 31 A RT.02/RW.04
Registration Date
Apr 30, 2024
Expiry Date
Dec 31, 2028
Product Type
Diagnostic Cardiology Equipment
Percutaneous catheter.
Non Electromedic Sterile

