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GEM PREMIER 3500 (pH, pCO2, pO2, HcT) Sensor and Reagent Catridge - Indonesia BPOM Medical Device Registration

GEM PREMIER 3500 (pH, pCO2, pO2, HcT) Sensor and Reagent Catridge is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101713132. The device is manufactured by INSTRUMENTATION LABORATORY COMPANY. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.

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BPOM Registered
Risk Class Kelas Resiko : C
GEM PREMIER 3500 (pH, pCO2, pO2, HcT) Sensor and Reagent Catridge
Analysis ID: AKL 20101713132

Risk Classification

Kelas Resiko : C

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 25, 2024

Expiry Date

Dec 31, 2027

Product Type

Clinical Chemistry Test System

Multi parameter clinical chemistry test system

Invitro Diagnostics

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