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"Kingsle" alpha-fetoprotein assay kit - Taiwan Registration fdd3effcd1d821fe09613bba2498378c

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.

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fdd3effcd1d821fe09613bba2498378c
Registration Details
Taiwan FDA Registration: fdd3effcd1d821fe09613bba2498378c
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Device Details

"Kingsle" alpha-fetoprotein assay kit
TW: โ€œ้‡‘ๆ–ฏ็ˆพโ€ ็”ฒ่ƒŽ่›‹็™ฝๆธฌๅฎš่ฉฆๅŠ‘็›’
Risk Class 2

Registration Details

fdd3effcd1d821fe09613bba2498378c

DHA09200103609

Company Information

Product Details

It is used for the quantitative detection of alpha-fetoprotein (AFP) content in human serum or plasma in vitro.

A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology

C.6010 Mass phase antigen immunoassay system;; A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products

Chinese goods;; Input;; QMS/QSD

Dates and Status

Jun 23, 2021

Jun 23, 2026