Taiwan FDA registration 47c8b62828cc8cf848feaa9751e06927

cobas HBV

TW: 羅氏可霸斯全自動B型肝炎病毒量核酸檢驗組
Taiwan flagTaiwan·Risk Class 3·MD·ROCHE MOLECULAR SYSTEMS, INC.·Registered Apr 01, 2018 – Apr 01, 2028Active
Registration details
Analysis ID
47c8b62828cc8cf848feaa9751e06927
License Form
Ministry of Health Medical Device Import No. 030533
Customs Code
DHA05603053306
Company information
Manufacturer Country
United States
Authorized Representative
ROCHE DIAGNOSTICS LTD.
Product details
Intended Use
This product is a nucleic acid amplification test for the quantitative detection of HBV DNA in EDTA plasma or serum in patients infected with hepatitis B virus (HBV).
Product Type (Level 1)
B Hematology and pathology devices
Product Type (Level 2)
B4020 Analyze specific reagents
Import Information
Imported from abroad
Dates and status
Registration Date
Apr 01, 2018
Expiry Date
Apr 01, 2028
Companies making similar products

Top companies providing products similar to "cobas HBV"

Recent registrations

Recently registered similar products

About this record

Access comprehensive regulatory information for cobas HBV in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 47c8b62828cc8cf848feaa9751e06927 and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including ROCHE MOLECULAR SYSTEMS, INC., and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

Free DatabasePowered by Pure Global AI89,000+ Devices1 Competitors1 Recent Registrations