Taiwan FDA registration fbae7e0120d4319bb71502725200d868

BIOPHEN APIXABAN CONTROL

TW: 海分生醫APIXABAN品管液
Taiwan flagTaiwan·Risk Class 2·MD·HYPHEN BioMed·Registered Mar 15, 2016 – Mar 15, 2026Expired
Registration details
Analysis ID
fbae7e0120d4319bb71502725200d868
License Form
Ministry of Health Medical Device Import No. 028295
Customs Code
DHA05602829501
Company information
Manufacturer
HYPHEN BioMed
Manufacturer Country
France
Authorized Representative
SYSMEX TAIWAN CO., LTD.
Product details
Intended Use
This product is a quality control solution containing two kinds of APIXABAN concentration of human plasmaban, which is used for quality control of measuring APIXABAN using anti-Xa colorimetric method.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A1660 Quality Control Materials (Analytical and Non-Analytical)
Import Information
Imported from abroad
Dates and status
Registration Date
Mar 15, 2016
Expiry Date
Mar 15, 2026
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About this record

Access comprehensive regulatory information for BIOPHEN APIXABAN CONTROL in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fbae7e0120d4319bb71502725200d868 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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