Pure Global

SMART Diagnostic HCV Strip - Indonesia BPOM Medical Device Registration

SMART Diagnostic HCV Strip is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305120841. The device is manufactured by BLUE CROSS BIO-MEDICAL (BEIJING) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. PERUSAHAAN PERSEROAN (PERSERO) INDONESIA FARMA.

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 : D
SMART Diagnostic HCV Strip
Analysis ID: AKL 30305120841

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

China

AR Address

Jl. Tambak No. 2 RT 013 RW 008

Registration Date

Feb 25, 2021

Expiry Date

Feb 11, 2024

Product Type

Immunological Test System

Antinuclear antibody immunological test system.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing