Taiwan FDA registration 4983c7590eb66aad8a3d8ebd46d10caa
"Opron" Gastric pylori rapid test reagent (unsterilized)
TW: “歐普隆” 胃幽門桿菌快速檢驗試劑(未滅菌)
Taiwan·Risk Class 1·OPERON, S.A.·Registered Sep 10, 2021 – Sep 10, 2026ActiveRegistration details
- Analysis ID
- 4983c7590eb66aad8a3d8ebd46d10caa
- Customs Code
- DHA09402264400
Company information
- Manufacturer
- OPERON, S.A.
- Manufacturer Country
- Spain
- Authorized Representative
- GREAT MEDICAL SCIENCE INC.
Product details
- Intended Use
- Limited to the classification and grading management of medical devices, the first level identification range of "Helicobacter serum reagent (C.0003)".
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.0003 螺旋桿菌屬血清試劑
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Sep 10, 2021
- Expiry Date
- Sep 10, 2026
About this record
Access comprehensive regulatory information for "Opron" Gastric pylori rapid 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 4983c7590eb66aad8a3d8ebd46d10caa and manufactured by OPERON, S.A.. The authorized representative in Taiwan is GREAT MEDICAL SCIENCE INC..
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