GeneAll® Hybrid-R™ Blood RNA - Indonesia BPOM Medical Device Registration
GeneAll® Hybrid-R™ Blood RNA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10204124679. The device is manufactured by GENEALL BIOTECHNOLOGY CO., LTD., from Korea, and is classified as Risk Class Kelas Resiko : A. 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 : 1
Manufacturer
GENEALL BIOTECHNOLOGY CO., LTD.,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
Jul 30, 2021
Expiry Date
Dec 31, 2025
Product Type
Reagents and Specimen Providers
General purpose reagent.
Invitro Diagnostics
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VIASURE Zika, Dengue & Chikungunya Real Time PCR Detection Kit 12 x 8-well strips
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VIASURE Sexually Transmitted Diseases Real Time PCR Detection Kit
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VIASURE Dengue Virus Real Time PCR Detection Kit
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STANDARD F TnI FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.
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.

