GENTAFIX 3 PMMA Bone Cement - Indonesia BPOM Medical Device Registration
GENTAFIX 3 PMMA Bone Cement is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31302915218. The device is manufactured by TEKNIMED S.A.S from France, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. MAINSTAY OF MEDIKA SEJAHTERA ABADI.
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 : 3
Manufacturer
TEKNIMED S.A.SCountry of Origin
France
Authorized Representative
PT. MAINSTAY OF MEDIKA SEJAHTERA ABADIAR Address
JL. RUNGKUT ASRI BARAT I/46 SURABAYA
Registration Date
Aug 30, 2023
Expiry Date
Aug 19, 2028
Product Type
Prosthetic Orthopedic Equipment
Polymethylmethacrylate (PMMA) bone cement with drug
Non Electromedic Sterile

