NORTROL - Indonesia BPOM Medical Device Registration
NORTROL is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101810740. The device is manufactured by THERMO FISHER SCIENTIFIC OY. from Finland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
THERMO FISHER SCIENTIFIC OY.Country of Origin
Finland
Authorized Representative
PT. ENSEVAL MEDIKA PRIMAAR Address
JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG
Registration Date
May 31, 2022
Expiry Date
Dec 31, 2025
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
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