Taiwan FDA registration c59d6a09eec30b64f7f239b8c77fc4fa

Speedbassen Rotavirus/Adenovirus Antigen Detection Reagent (Unsterilized)

TW: 速得百森輪狀病毒/腺病毒抗原檢測試劑(未滅菌)
Taiwan flagTaiwan·Risk Class 1·SD BIOSENSOR, Inc.·Registered Apr 27, 2023 – Apr 27, 2028Active
Registration details
Analysis ID
c59d6a09eec30b64f7f239b8c77fc4fa
Customs Code
DHA09402310004
Company information
Manufacturer
SD BIOSENSOR, Inc.
Manufacturer Country
Korea, Republic of
Authorized Representative
CREATIVE LIFE SCIENCE 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
Input;; QMS/QSD
Dates and status
Registration Date
Apr 27, 2023
Expiry Date
Apr 27, 2028
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About this record

Access comprehensive regulatory information for Speedbassen Rotavirus/Adenovirus 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 c59d6a09eec30b64f7f239b8c77fc4fa and manufactured by SD BIOSENSOR, Inc.. The authorized representative in Taiwan is CREATIVE LIFE SCIENCE CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including SD BIOSENSOR, 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.

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