STANDARD F TnI FIA - Indonesia BPOM Medical Device Registration
STANDARD F TnI FIA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421924. The device is manufactured by SD BIOSENSOR HEALTHCARE PVT. LTD. from India, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is STANDARD BIOSENSOR INDONESIA.
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
SD BIOSENSOR HEALTHCARE PVT. LTD.Country of Origin
India
Authorized Representative
STANDARD BIOSENSOR INDONESIAAR Address
L'AVENUE BUILDING UNIT C, LT. 21, JL. RAYA PASAR MINGGU KAV. 16
Registration Date
Oct 02, 2024
Expiry Date
Jan 18, 2029
Product Type
Clinical Chemistry Test System
Creatine phosphokinase/creatine kinase or isoenzymes test system (card)
Invitro Diagnostics
STANDARD F TnI/CK-MB Combo FIA
STANDARD F iFOB FIA
STANDARD F CK-MB FIA
STANDARD F D-dimer FIA
STANDARD F LH FIA
STANDARD F T3
STANDARD F fT4
STANDARD F T4
STANDARD F B-hCG FIA
STANDARD F TSH FIA
VIASURE Monkeypox virus Real Time PCR Detection Kit 12 x 8-well strips
CERTEST BIOTEC S.L
VIASURE Zika, Dengue & Chikungunya Real Time PCR Detection Kit 12 x 8-well strips
CERTEST BIOTEC S.L
VIASURE Dengue Virus Real Time PCR Detection Kit
CERTEST BIOTEC S.L
VIASURE Sexually Transmitted Diseases Real Time PCR Detection Kit
CERTEST BIOTEC S.L
STANDARD F TnI/CK-MB Combo FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.
STANDARD F iFOB FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.
STANDARD F NT-proBNP FIA
SD BIOSENSOR
STANDARD F CK-MB FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.
STANDARD F D-dimer FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.
STANDARD F T3
SD BIOSENSOR HEALTHCARE PVT. LTD.