Taiwan FDA registration 34fbad440e690236de88f4ae0bc13a19
"Oplon" respiratory adenovirus test reagent (unsterilized)
TW: “歐普隆” 呼吸道腺病毒檢驗試劑(未滅菌)
Registration details
- Analysis ID
- 34fbad440e690236de88f4ae0bc13a19
- Customs Code
- DHA09402266406
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 range of the classification and grading management method of medical equipment "adenovirus serum reagent (C.3020)".
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3020 腺病毒血清試劑
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Sep 23, 2021
- Expiry Date
- Sep 23, 2026
About this record
Access comprehensive regulatory information for "Oplon" respiratory adenovirus 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 34fbad440e690236de88f4ae0bc13a19 and manufactured by OPERON, S.A.. The authorized representative in Taiwan is GREAT MEDICAL SCIENCE INC..
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