Taiwan FDA registration 72a0b407c55e4bbf455f3d52bb8fc9c3
"RapiGEN" H.pylori (Non-Sterile)
TW: "睿軍" 幽門桿菌快速檢測試劑 (未滅菌)
Taiwan·Risk Class 1·MD·RAPIGEN INC.·Registered Dec 12, 2017 – Dec 12, 2022ExpiredRegistration details
- Analysis ID
- 72a0b407c55e4bbf455f3d52bb8fc9c3
- License Form
- Ministry of Health Medical Device Import No. 018597
- Customs Code
- DHA09401859702
Company information
- Manufacturer
- RAPIGEN INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Medley Limited
Product details
- Intended Use
- Limited to the first level identification range of the Measures for the Administration of Medical Devices "Helicobacter Serological Reagent (C.0003)".
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C0003 Helicobacter serological reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 12, 2017
- Expiry Date
- Dec 12, 2022
About this record
Access comprehensive regulatory information for "RapiGEN" H.pylori (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 72a0b407c55e4bbf455f3d52bb8fc9c3 and manufactured by RAPIGEN INC.. The authorized representative in Taiwan is Medley Limited.
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