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GEM System Evaluator Lvl 2 - Indonesia BPOM Medical Device Registration

GEM System Evaluator Lvl 2 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323229. The device is manufactured by INSTRUMENTATION LABORATORY COMPANY from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.

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BPOM Registered
Risk Class Kelas Resiko : B
GEM System Evaluator Lvl 2
Analysis ID: AKL 20101323229

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. ENSEVAL MEDIKA PRIMA

AR Address

JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG

Registration Date

Jun 28, 2024

Expiry Date

Dec 31, 2027

Product Type

Clinical Chemistry Test System

Quality control material (assayed and unassayed) (cair)

Invitro Diagnostics

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