STANDARD™ Glucose Control Solution - Indonesia BPOM Medical Device Registration
STANDARD™ Glucose Control Solution is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101910592. The device is manufactured by SD BIOSENSOR INC. 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 BIOSENSOR INC.Country 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
Jun 29, 2022
Expiry Date
Dec 30, 2025
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
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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.

