HISCL HBeAg Assay Kit - Indonesia BPOM Medical Device Registration
HISCL HBeAg Assay Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305127609. The device is manufactured by JAPAN LYOPHILIZATION LABORATORY. from Japan, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is SYSMEX 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.
Risk Classification
Product Class
Kelas : 3
Manufacturer
JAPAN LYOPHILIZATION LABORATORY.Country of Origin
Japan
Authorized Representative
SYSMEX INDONESIAAR Address
Cyber 2 Tower, 5th Floor Unit E Jl. HR. Rasuna Said Blok X.5 No.13
Registration Date
Nov 26, 2024
Expiry Date
Jan 26, 2028
Product Type
Immunological Test System
Antimitochondrial antibody immunological test system.
Invitro Diagnostics
HISCL Anti-HBe Assay Kit
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