Taiwan FDA registration c091461fa48c48a0063e36a3914560af

"Asian Gene" Adenovirus Antigen Rapid Test Reagent (Unsterilized)

TW: "亞洲基因" 腺病毒抗原快速檢驗試劑 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·Asia Gene Technology Co., Ltd. Shanhua Factory·Registered Sep 18, 2023 – Sep 18, 2028Active
Registration details
Analysis ID
c091461fa48c48a0063e36a3914560af
Company information
Manufacturer Country
Taiwan, Province of China
Product details
Intended Use
It is limited to the first-level identification scope of the classification and grading management measures for medical devices "adenovirus serum reagents (C.3020)" and "microbial sample collection and delivery equipment (C.2900)".
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.3020 腺病毒血清試劑;; C.2900 微生物樣本收集及輸送器材
Import Information
QMS/QSD;; 國產
Dates and status
Registration Date
Sep 18, 2023
Expiry Date
Sep 18, 2028
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About this record

Access comprehensive regulatory information for "Asian Gene" Adenovirus Antigen Rapid Test 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 c091461fa48c48a0063e36a3914560af and manufactured by Asia Gene Technology Co., Ltd. Shanhua Factory. 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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