Taiwan FDA registration 7a3bde0a72fa6c811ace2fbdc08fc916
"Haifeng Biomedicine" Dabigatran correction solution
TW: “海奉生物醫學” Dabigatran 校正液
Registration details
- Analysis ID
- 7a3bde0a72fa6c811ace2fbdc08fc916
- Customs Code
- DHA05603415507
Company information
- Manufacturer
- HYPHEN BioMed
- Manufacturer Country
- France
- Authorized Representative
- SYSMEX TAIWAN CO., LTD.
Product details
- Intended Use
- This product is lyophilized human plasma doped with different concentrations of Dabigatran for correction of Dabigatran measurements.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1150 Calibrated Products
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Nov 09, 2020
- Expiry Date
- Nov 09, 2025
About this record
Access comprehensive regulatory information for "Haifeng Biomedicine" Dabigatran correction solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7a3bde0a72fa6c811ace2fbdc08fc916 and manufactured by HYPHEN BioMed. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..
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