Taiwan FDA registration 7c4404ee7f7fe18e34792ad17e706a07

"Haifeng Biomedical" Dabigatran quality control liquid

TW: “海奉生物醫學” Dabigatran品管液

Taiwan·Risk Class 2·HYPHEN BioMed·Registered Feb 08, 2021 – Feb 08, 2026Expired

Registration details

Analysis ID: 7c4404ee7f7fe18e34792ad17e706a07
Customs Code: DHA05603435900

Company information

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

Product details

Intended Use: This product is a lyophilized human plasma doped with different concentrations of Dabigatran for Dabigatran analysis.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical)
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Feb 08, 2021
Expiry Date: Feb 08, 2026

About this record

Access comprehensive regulatory information for "Haifeng Biomedical" Dabigatran 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 7c4404ee7f7fe18e34792ad17e706a07 and manufactured by HYPHEN BioMed. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..

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