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Elva HbA1c Analytical Column - Indonesia BPOM Medical Device Registration

Elva HbA1c Analytical Column is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207420069. The device is manufactured by WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO., LTD, P.R CHINA from China, 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
Elva HbA1c Analytical Column
Analysis ID: AKL 20207420069

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

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 06, 2024

Expiry Date

Dec 31, 2026

Product Type

Haematology Package and Kit

Glycosylated hemoglobin assay.

Invitro Diagnostics

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DJ Fang

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