STANDARD F fT4 - Indonesia BPOM Medical Device Registration
STANDARD F fT4 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221910. The device is manufactured by SD BIOSENSOR from Korea, 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 BIOSENSORCountry of Origin
Korea
Authorized Representative
STANDARD BIOSENSOR INDONESIAAR Address
L'Avenue Office Tower Lt.21 Unit C, Jl. Raya Pasar Minggu Kav.16 Kel. Pancoran Kec. Pancoran , Jakarta Selatan
Registration Date
Nov 02, 2022
Expiry Date
Dec 30, 2025
Product Type
Clinical Chemistry Test System
Thyroxine-binding globulin test system (card)
Invitro Diagnostics
STANDARD M10 DENV 1-4
STANDARD F TSH-II FIA
STANDARD Lipidocare Analyzer (NB)
STANDARD F NT-proBNP FIA
STANDARD™ F hs-CRP
STANDARD M10 MTB/NTM
SD BIOSENSOR TB-Feron SPP
STANDARD Q Dengue Duo Test
STANDARD™ Q H pylori Ab Test
STANDARD Q H pylori Ag Test
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 FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.
STANDARD F iFOB FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.
STANDARD F TnI/CK-MB Combo 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.