Taiwan FDA registration 751c52f269bd99712614554fff57761c
BIOPHEN APIXABAN CALIBRATOR LOW
TW: 海分生醫APIXABAN校正液低值
Taiwan·Risk Class 2·MD·HYPHEN BioMed·Registered Mar 17, 2016 – Mar 17, 2026ExpiredRegistration details
- Analysis ID
- 751c52f269bd99712614554fff57761c
- License Form
- Ministry of Health Medical Device Import No. 028299
- Customs Code
- DHA05602829906
Company information
- Manufacturer
- HYPHEN BioMed
- Manufacturer Country
- France
- Authorized Representative
- SYSMEX TAIWAN CO., LTD.
Product details
- Intended Use
- This product is a human plasma sleeve used to correct Apixaban analysis using anti-Xa colorimetric method.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1150 calibrate
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 17, 2016
- Expiry Date
- Mar 17, 2026
About this record
Access comprehensive regulatory information for BIOPHEN APIXABAN CALIBRATOR LOW in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 751c52f269bd99712614554fff57761c and manufactured by HYPHEN BioMed. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..
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