VivaDiag ™ POCT Analyzer (VIM02) - Indonesia BPOM Medical Device Registration

VivaDiag ™ POCT Analyzer (VIM02) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102220281. The device is manufactured by VIVACHEK BIOTECH (HANGZHOU) CO., LTD., CHINA from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MAIN MEDICAL CHAKRA.

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BPOM Registered

Risk Class Kelas Resiko : B

VivaDiag ™ POCT Analyzer (VIM02)

Analysis ID: AKL 20102220281

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

VIVACHEK BIOTECH (HANGZHOU) CO., LTD., CHINA

Country of Origin

China

Authorized Representative

PT. MAIN MEDICAL CHAKRA

AR Address

FORESTA BUSINESS LOFT 6 No. 10, Jl. Raya Boulevard Utara BSD City, Desa/Kelurahan Lengkong Kulon

Registration Date

Oct 27, 2022

Expiry Date

Sep 10, 2025

Product Type

Clinical Laboratory Equipment

Instrumentation for clinical multiplex test systems.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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