Taiwan FDA registration dd470593e5701c0f749203054af989ef

BIOPHEN APIXABAN CALIBRATOR

TW: 海分生醫APIXABAN校正液
Taiwan flagTaiwan·Risk Class 2·MD·HYPHEN BioMed·Registered Mar 17, 2016 – Mar 17, 2026Expired
Registration details
Analysis ID
dd470593e5701c0f749203054af989ef
License Form
Ministry of Health Medical Device Import No. 028298
Customs Code
DHA05602829804
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
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About this record

Access comprehensive regulatory information for BIOPHEN APIXABAN CALIBRATOR in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number dd470593e5701c0f749203054af989ef and manufactured by HYPHEN BioMed. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including HYPHEN BioMed, and 1 recent registrations in the same category. 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.

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