Taiwan FDA registration 2fb762849290ce9b81016332c4848cb9

Lumipulse G HBsAg-Quant

TW: 錄祕帕斯GB型肝炎病毒表面抗原定量檢驗試劑
Taiwan flagTaiwan·Risk Class 3·MD·FUJIREBIO INC. SAGAMIHARA FACILITY.·Registered Aug 07, 2018 – Aug 07, 2028Active
Registration details
Analysis ID
2fb762849290ce9b81016332c4848cb9
License Form
Ministry of Health Medical Device Import No. 031402
Customs Code
DHA05603140209
Company information
Manufacturer Country
Japan
Authorized Representative
Grand Marquis IVD CO., LTD.
Product details
Intended Use
Quantitative determination of hepatitis B viral surface antigen (HBsAg) in human serum or plasma with the Secret Paz G System. This product is used to assist in the diagnosis of hepatitis B virus infection.
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
Aug 07, 2018
Expiry Date
Aug 07, 2028
Companies making similar products

Top companies providing products similar to "Lumipulse G HBsAg-Quant"

Recent registrations

Recently registered similar products

About this record

Access comprehensive regulatory information for Lumipulse G HBsAg-Quant in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 2fb762849290ce9b81016332c4848cb9 and manufactured by FUJIREBIO INC. SAGAMIHARA FACILITY.. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including FUJIREBIO INC., HACHIOJI FACILITY, 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