Pure Global

VAZYME High Sensitivity Cardiac Troponin I (hs-cTnl) Test Kit (Quantum Dots Fluorescence Immunochromatography) - Indonesia BPOM Medical Device Registration

VAZYME High Sensitivity Cardiac Troponin I (hs-cTnl) Test Kit (Quantum Dots Fluorescence Immunochromatography) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101222038. The device is manufactured by NANJING VAZYME MEDICAL TECHNOLOGY.,LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. HEALTHY FAMILY FOCUS.

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
VAZYME High Sensitivity Cardiac Troponin I (hs-cTnl) Test Kit (Quantum Dots Fluorescence Immunochromatography)
Analysis ID: AKL 20101222038

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. HEALTHY FAMILY FOCUS

AR Address

Komplek Delta Building Blok B 1-2, Jalan Suryopranoto No. 1-9

Registration Date

Nov 21, 2022

Expiry Date

Mar 08, 2027

Product Type

Clinical Chemistry Test System

Creatine phosphokinase/creatine kinase or isoenzymes test system (card)

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Other Products from NANJING VAZYME MEDICAL TECHNOLOGY.,LTD
Products from the same manufacturer (1 products)