Taiwan FDA registration 0457984c252e99386c3f2032f88bf5a1
"Opron" Clostridium difficile antigen test reagent (unsterilized)
TW: “歐普隆” 困難梭狀桿菌抗原檢驗試劑(未滅菌)
Taiwan·Risk Class 1·OPERON, S.A.·Registered Sep 11, 2021 – Sep 11, 2026ActiveRegistration details
- Analysis ID
- 0457984c252e99386c3f2032f88bf5a1
- Customs Code
- DHA09402264706
Company information
- Manufacturer
- OPERON, S.A.
- Manufacturer Country
- Spain
- Authorized Representative
- GREAT MEDICAL SCIENCE INC.
Product details
- Intended Use
- Limited to the first level identification scope of the Measures for the Classification and Grading of Medical Devices "Microbial Identification and Determination Equipment (C.2660)".
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.2660 微生物鑑別及測定器材
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Sep 11, 2021
- Expiry Date
- Sep 11, 2026
About this record
Access comprehensive regulatory information for "Opron" Clostridium difficile antigen 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 0457984c252e99386c3f2032f88bf5a1 and manufactured by OPERON, S.A.. The authorized representative in Taiwan is GREAT MEDICAL SCIENCE INC..
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