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VivaDiag™ D-Dimer Test Kit (FIA) - Indonesia BPOM Medical Device Registration

VivaDiag™ D-Dimer Test Kit (FIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207027483. The device is manufactured by VIVACHEK BIOTECH (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MAIN MEDICAL CHAKRA.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : C
VivaDiag™ D-Dimer Test Kit (FIA)
Analysis ID: AKL 20207027483

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

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

Jun 11, 2023

Expiry Date

Sep 10, 2025

Product Type

Haematology Package and Kit

Fibrinogen/fibrin degradation products assay.

Invitro Diagnostics

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