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GEM Premier™ 5000 Analyzer and Accessories - Indonesia BPOM Medical Device Registration

GEM Premier™ 5000 Analyzer and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102026324. The device is manufactured by INSTRUMENTATION LABORATORIES CO, USA from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ENSEVAL MEDIKA PRIMA.

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BPOM Registered
Risk Class Kelas Resiko : B
GEM Premier™ 5000 Analyzer and Accessories
Analysis ID: AKL 20102026324

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

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 Laboratory Equipment

Instrumentation for clinical multiplex test systems.

Invitro Diagnostics

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