LABSYSTEMS Neonatal Galactose - Indonesia BPOM Medical Device Registration
LABSYSTEMS Neonatal Galactose is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101322805. The device is manufactured by LABSYSTEMS DIAGNOSTICS OY. from Finland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. GLOBAL MALLINDO SCIENCE.
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
LABSYSTEMS DIAGNOSTICS OY.Country of Origin
Finland
Authorized Representative
PT. GLOBAL MALLINDO SCIENCEAR Address
Rukan Mitra Matraman Blok A1 No. 23 RT.004/RW.004, Kode Pos 13150, Kel. Kebon Manggis, Kec. Matraman, Kota Jakarta Timur, Prov. DKI Jakarta
Registration Date
Jul 15, 2024
Expiry Date
Dec 31, 2025
Product Type
Clinical Chemistry Test System
Galactose test system (kit & cair)
Invitro Diagnostics
LABSYSTEMS Neonatal 17-OH-Progesterone FEIA
LABSYSTEMS Neonatal Phenylalanine
LABSYSTEMS NS Reader
LABSYSTEMS Neonatal Screening Automate NS2400
LABSYSTEMS Neonatal hTSH EIA
LABSYSTEMS Neonatal hTSH FEIA Plus
LABSYSTEMS Neonatal G6PD
LABSYSTEMS Neonatal 17-OH-Progesterone FEIA
LABSYSTEMS DIAGNOSTICS OY.
LABSYSTEMS Neonatal Phenylalanine
LABSYSTEMS DIAGNOSTICS OY.
LABSYSTEMS NS Reader
LABSYSTEMS DIAGNOSTICS OY.
LABSYSTEMS Neonatal Screening Automate NS2400
LABSYSTEMS DIAGNOSTICS OY.
LABSYSTEMS Neonatal G6PD
LABSYSTEMS DIAGNOSTICS OY.
LABSYSTEMS Neonatal hTSH EIA
LABSYSTEMS DIAGNOSTICS OY.
WUHAN Immune Quantitative Analyser
WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
WUHAN hs-CRP Rapid Test
WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
WUHAN PCT Rapid Test Kit
WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
WUHAN NT-pro BNP Rapid Test
WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.