ZENTECH Neonatal Biotonidase Screening Assay - Indonesia BPOM Medical Device Registration
ZENTECH Neonatal Biotonidase Screening Assay is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101510244. The device is manufactured by ZENTECH S.A. from Belgium, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is FAITHFUL MEDICAL GRACE.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ZENTECH S.A.Country of Origin
Belgium
Authorized Representative
FAITHFUL MEDICAL GRACEAR Address
Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89
Registration Date
Nov 26, 2021
Expiry Date
Jul 02, 2026
Product Type
Clinical Chemistry Test System
Biotinidase test system (kit & cair)
Invitro Diagnostics
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