NOVA test Helicobacter pylori Total Antibody Test (Cassette) - Indonesia BPOM Medical Device Registration
NOVA test Helicobacter pylori Total Antibody Test (Cassette) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303520062. The device is manufactured by ATLAS LINK TECHNOLOGY CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. LABORA DIAGNOSTIC PARTNERS.
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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
ATLAS LINK TECHNOLOGY CO., LTDCountry of Origin
China
Authorized Representative
PT. LABORA DIAGNOSTIC PARTNERSAR Address
MITRA DIAGNOSTIK LABORA
Registration Date
Jan 23, 2025
Expiry Date
Mar 08, 2028
Product Type
Serological Reagents
Campylobacter fetus serological reagents.
Invitro Diagnostics
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