Pure Global

BIO-RAD Monolisa HCV Ag-Ab Ultra V2 - Indonesia BPOM Medical Device Registration

BIO-RAD Monolisa HCV Ag-Ab Ultra V2 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305420568. The device is manufactured by BIO-RAD (STEENVOORDE) from France, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. ANDAMAN MEDICAL INDONESIA.

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
BIO-RAD Monolisa HCV Ag-Ab Ultra V2
Analysis ID: AKL 30305420568

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

France

Authorized Representative

PT. ANDAMAN MEDICAL INDONESIA

AR Address

Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma

Registration Date

Nov 20, 2024

Expiry Date

Aug 13, 2029

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
Other Products from BIO-RAD (STEENVOORDE)
Products from the same manufacturer (2 products)