Taiwan FDA registration 1c7caa136d9c0740381bb4a092d91da8
"Opron" Clostridium Difficultia antigen and toxin test reagent (unsterilized)
TW: “歐普隆” 困難梭狀桿菌抗原與毒素檢驗試劑(未滅菌)
Taiwan·Risk Class 1·OPERON, S.A.·Registered Sep 10, 2021 – Sep 10, 2026ActiveRegistration details
- Analysis ID
- 1c7caa136d9c0740381bb4a092d91da8
- Customs Code
- DHA09402264301
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
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Sep 10, 2021
- Expiry Date
- Sep 10, 2026
About this record
Access comprehensive regulatory information for "Opron" Clostridium Difficultia antigen and toxin 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 1c7caa136d9c0740381bb4a092d91da8 and manufactured by OPERON, S.A.. The authorized representative in Taiwan is GREAT MEDICAL SCIENCE INC..
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