Pure Global

VivaDiag™ Alpha Fetoprotein Test Kit (FIA) - Indonesia BPOM Medical Device Registration

VivaDiag™ Alpha Fetoprotein Test Kit (FIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306420034. 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 CAKRA MEDIKA UTAMA.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
VivaDiag™ Alpha Fetoprotein Test Kit (FIA)
Analysis ID: AKL 20306420034

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

CAKRA MEDIKA UTAMA

AR Address

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

Registration Date

Mar 15, 2024

Expiry Date

Nov 23, 2028

Product Type

Tumor Antigen Immunologic Test System

AFP-L3% immunological test system.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing