Taiwan FDA registration fb438ab203431bfd18ffee1ea94b6722
"Haifeng Biomedical" activates factor 10 direct inhibitors
TW: "海奉生物醫學" 活化第十因子直接抑制劑
Taiwan·Risk Class 2·HYPHEN BioMed·Registered Dec 25, 2023 – Dec 25, 2028ActiveRegistration details
- Analysis ID
- fb438ab203431bfd18ffee1ea94b6722
- Customs Code
- DHA05603624403
Company information
- Manufacturer
- HYPHEN BioMed
- Manufacturer Country
- France
- Authorized Representative
- SYSMEX TAIWAN CO., LTD.
Product details
- Intended Use
- The concentration of direct inhibitor of activated factor 10 (DiXaI) in human plasma after citrate treatment was quantitatively detected in vitro by anti-activated factor 10 colorimetric method by automated method. This product can be used to assist in the diagnosis of anticoagulant status in patients treated with oral anticoagulants (Apixaban, Rivaroxaban and Edoxaban).
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.7525 Heparin analysis
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Dec 25, 2023
- Expiry Date
- Dec 25, 2028
About this record
Access comprehensive regulatory information for "Haifeng Biomedical" activates factor 10 direct inhibitors in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fb438ab203431bfd18ffee1ea94b6722 and manufactured by HYPHEN BioMed. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..
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