Taiwan FDA registration 5b52bead0a97dbcd1c071cbd5bcf35e5

Rotavirus/adenovirus rapid test (unsterilized)

TW: "傑試可" 輪狀病毒/腺病毒快速檢測試劑(未滅菌)
Taiwan flagTaiwan·Risk Class 1·HANGZHOU ALLTEST BIOTECH CO., LTD.·Registered Jan 17, 2022 – Jan 17, 2027Active
Registration details
Analysis ID
5b52bead0a97dbcd1c071cbd5bcf35e5
Customs Code
DHA09600459807
Company information
Manufacturer Country
China
Authorized Representative
Chuang An Biomedical Co., Ltd.
Product details
Intended Use
Limited to the classification and grading management of medical devices, the first level of "polio virus serum reagent (C.3405)" and "adenovirus serum reagent (C.3020)" identification range.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.3020 腺病毒血清試劑;; C.3405 小兒麻痺病毒血清試劑
Import Information
QMS/QSD;; Chinese goods;; input
Dates and status
Registration Date
Jan 17, 2022
Expiry Date
Jan 17, 2027
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About this record

Access comprehensive regulatory information for Rotavirus/adenovirus rapid test (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 5b52bead0a97dbcd1c071cbd5bcf35e5 and manufactured by HANGZHOU ALLTEST BIOTECH CO., LTD.. The authorized representative in Taiwan is Chuang An Biomedical Co., Ltd..

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including OPERON, S.A., ABBOTT DIAGNOSTICS KOREA INC, and 2 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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