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BIOTIME HbA1c Rapid Quantitative Test - Indonesia BPOM Medical Device Registration

BIOTIME HbA1c Rapid Quantitative Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101520198. The device is manufactured by XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. GOLDEN MEDIKA MANDIRI.

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BPOM Registered
Risk Class Kelas Resiko : B
BIOTIME HbA1c Rapid Quantitative Test
Analysis ID: AKL 20101520198

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. GOLDEN MEDIKA MANDIRI

AR Address

Jl. Raya Kalirungkut 27 Blok C-65

Registration Date

Jan 24, 2025

Expiry Date

Sep 03, 2029

Product Type

Clinical Chemistry Test System

Hemoglobin A1c test system.

Invitro Diagnostics

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