SKY TEST HCV Strip - Indonesia BPOM Medical Device Registration
SKY TEST HCV Strip is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305817613. The device is manufactured by HANGZHOU CLONGENE BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. NOBLE BLESSINGS OF SIPOLIN.
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
HANGZHOU CLONGENE BIOTECH CO., LTD.Country of Origin
China
Authorized Representative
PT. NOBLE BLESSINGS OF SIPOLINAR Address
Jl. H. Midi II No.6 Rt.05/ RW.02 Limo Cinere, Depok 16515
Registration Date
Dec 17, 2021
Expiry Date
Dec 16, 2024
Product Type
Immunological Test System
Antinuclear antibody immunological test system.
Invitro Diagnostics
ACCURATE HCV (WB/S/P) CASSETTE
ZHEJIANG ORIENT GENE BIOTECH CO.,LTD.
GLORY DIAGNOSTICS – ANTI HCV STRIP
LINEAR CHEMICALS S.L.U
GLORY DIAGNOSTICS – ANTI HCV CASSETTE
LINEAR CHEMICALS, S.L.U
GLORY DIAGNOSTICS – HBsAg CASSETTE
LINEAR CHEMICALS S.L.U
GLORY DIAGNOSTICS – HBsAg STRIP
LINEAR CHEMICALS S.L.U
GLORY DIAGNOSTICS - MULTICALIBRATOR
LINEAR CHEMICALS S.L.U
GLORY DIAGNOSTICS-GLORY 127 Semi-automatic Biochemistry Analyzer & Accesssories
SINNOWA MEDICAL SCIENCE & TECHNOLOGY COMPANY LIMITED
GLORY DIAGNOSTICS - CHOLINESTERASE
LINEAR CHEMICALS S.L.U
WHEISMAN W-31L Lyse
WHEISMAN MEDICAL TECHNOLOGY CO., LTD.
WHEISMAN W-31D Diluent
WHEISMAN MEDICAL TECHNOLOGY CO., LTD