Taiwan FDA registration 685dba44d63d4c1d59b2c8a6cdba9d5b

and photoalpha-fetoprotein concentration and its heterogeneous (AFP-L3) ratio assay kit

TW: 和光甲胎蛋白濃度及其異質體(AFP-L3)比率測定試劑盒
Taiwan flagTaiwan·Risk Class 2·Fujifilm Healthcare Manufacturing Corporation My Office Common Site·Registered Jun 24, 2021 – Jun 24, 2026Expired
Registration details
Analysis ID
685dba44d63d4c1d59b2c8a6cdba9d5b
Customs Code
DHA05603466800
Company information
Manufacturer Country
Japan
Authorized Representative
MEDICARE PRODUCTS INC.
Product details
Intended Use
It is used for the determination of the heterogeneous ratio (AFP-L3%) and alpha-fetoprotein (AFP) concentration in serum. It can be used for auxiliary diagnosis of malignant tumors.
Product Type (Level 1)
A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
Product Type (Level 2)
C.6010 Mass phase antigen immunoassay system;; A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Jun 24, 2021
Expiry Date
Jun 24, 2026
About this record

Access comprehensive regulatory information for and photoalpha-fetoprotein concentration and its heterogeneous (AFP-L3) ratio assay kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 685dba44d63d4c1d59b2c8a6cdba9d5b and manufactured by Fujifilm Healthcare Manufacturing Corporation My Office Common Site. The authorized representative in Taiwan is MEDICARE PRODUCTS INC..

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.

Free DatabasePowered by Pure Global AI89,000+ Devices