Taiwan FDA registration ebf607d468cb69b2f5fd40b46a9f755c

Sea Separation Medical RIVAROXABAN correction solution and quality control liquid

TW: 海分生醫RIVAROXABAN校正液及品管液

Taiwan·Risk Class 2·HYPHEN BioMed·Registered Dec 22, 2015 – Dec 22, 2025Expired

Registration details

Analysis ID: ebf607d468cb69b2f5fd40b46a9f755c
Customs Code: DHA05602800209

Company information

Manufacturer: HYPHEN BioMed
Manufacturer Country: France
Authorized Representative: SYSMEX TAIWAN CO., LTD.

Product details

Intended Use: This product is suitable for measuring the concentration of Rivaroxaban plasma sleeve and quality solution for correction, and is suitable for anti-Xa colorimetric analysis by titration method, suitable for Biophen DiXal set.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1150 calibration;; A.1660 Quality control materials (analytical and non-analytical)
Import Information: import

Dates and status

Registration Date: Dec 22, 2015
Expiry Date: Dec 22, 2025

About this record

Access comprehensive regulatory information for Sea Separation Medical RIVAROXABAN correction solution and quality control liquid in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ebf607d468cb69b2f5fd40b46a9f755c and manufactured by HYPHEN BioMed. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..

This page provides complete technical specifications, regulatory compliance details. 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.