Taiwan FDA registration fdd3effcd1d821fe09613bba2498378c
"Kingsle" alpha-fetoprotein assay kit
TW: “金斯爾” 甲胎蛋白測定試劑盒
Taiwan·Risk Class 2·Beijing Strong Biotechnologies, Inc·Registered Jun 23, 2021 – Jun 23, 2026ExpiredRegistration details
- Analysis ID
- fdd3effcd1d821fe09613bba2498378c
- Customs Code
- DHA09200103609
Company information
- Manufacturer
- Beijing Strong Biotechnologies, Inc
- Manufacturer Country
- China
- Authorized Representative
- TUNYEN ENTERPRISE CORPORATION
Product details
- Intended Use
- It is used for the quantitative detection of alpha-fetoprotein (AFP) content in human serum or plasma in vitro.
- 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
- Chinese goods;; Input;; QMS/QSD
Dates and status
- Registration Date
- Jun 23, 2021
- Expiry Date
- Jun 23, 2026
About this record
Access comprehensive regulatory information for "Kingsle" alpha-fetoprotein 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 fdd3effcd1d821fe09613bba2498378c and manufactured by Beijing Strong Biotechnologies, Inc. The authorized representative in Taiwan is TUNYEN ENTERPRISE CORPORATION.
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