Taiwan FDA registration 3276674b97174d20bba5f59614849702

"Asian Gene" Helicobacter pylori antigen detection reagent (unsterilized)

TW: “亞洲基因” 幽門螺旋桿菌抗原檢測試劑 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·Asia Genomics Technology Co., Ltd. Factory 1·Registered Aug 08, 2023 – Aug 08, 2028Active
Registration details
Analysis ID
3276674b97174d20bba5f59614849702
Company information
Manufacturer Country
Taiwan, Province of China
Product details
Intended Use
Limited to the classification and grading management of medical devices, the first level identification range of "Helicobacter serum reagent (C.0003)".
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.0003 螺旋桿菌屬血清試劑
Import Information
QMS/QSD;; 國產
Dates and status
Registration Date
Aug 08, 2023
Expiry Date
Aug 08, 2028
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About this record

Access comprehensive regulatory information for "Asian Gene" Helicobacter pylori antigen detection reagent (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 3276674b97174d20bba5f59614849702 and manufactured by Asia Genomics Technology Co., Ltd. Factory 1. The authorized representative in Taiwan is Asia Gene Technology Co., Ltd. Shanhua Factory.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Asia Genomics Technology Co., Ltd. Factory 1, 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.

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