Taiwan FDA registration 2c9a7a0642d577ec1f08a5a9961cd926
Oprun Rapid Test Reagent for Rotavirus (Unsterilized)
TW: "歐普隆" 輪狀病毒快速檢驗試劑 (未滅菌)
Registration details
- Analysis ID
- 2c9a7a0642d577ec1f08a5a9961cd926
- Customs Code
- DHA09402241205
Company information
- Manufacturer
- OPERON, S.A.
- Manufacturer Country
- Spain
- Authorized Representative
- GREAT MEDICAL SCIENCE INC.
Product details
- Intended Use
- It is limited to the first level of identification scope of the "Poliovirus Serum Reagent (C.3405)" of the Measures for the Classification and Grading of Medical Devices.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3405 Poliomyelitis virus serum reagent
- Import Information
- import
Dates and status
- Registration Date
- Mar 25, 2021
- Expiry Date
- Mar 25, 2026
About this record
Access comprehensive regulatory information for Oprun Rapid Test Reagent for Rotavirus (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 2c9a7a0642d577ec1f08a5a9961cd926 and manufactured by OPERON, S.A.. The authorized representative in Taiwan is GREAT MEDICAL SCIENCE INC..
This page provides complete technical specifications, regulatory compliance details. 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.
Free DatabasePowered by Pure Global AI89,000+ Devices