Pure Global

"E-free" anti-Fyb blood group reagent (monostrain antibody) - Taiwan Registration 9edbd629268a3e7b9ab4a6bf9051b6eb

Access comprehensive regulatory information for "E-free" anti-Fyb blood group reagent (monostrain antibody) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9edbd629268a3e7b9ab4a6bf9051b6eb and manufactured by IMMUCOR, INC.. The authorized representative in Taiwan is Y.H. BIOTEK 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.

Free Database
Powered by Pure Global AI
89,000+ Devices
9edbd629268a3e7b9ab4a6bf9051b6eb
Registration Details
Taiwan FDA Registration: 9edbd629268a3e7b9ab4a6bf9051b6eb
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Details

"E-free" anti-Fyb blood group reagent (monostrain antibody)
TW: โ€œไพๅ…ๅฏโ€ๆŠ—Fyb่ก€ๅž‹่ฉฆๅŠ‘(ๅ–ฎๆ ชๆŠ—้ซ”)
Risk Class 2

Registration Details

9edbd629268a3e7b9ab4a6bf9051b6eb

DHA05603416306

Company Information

United States

Product Details

This product uses a direct agglutination test to detect Fyb (FY2) antigen on red blood cells.

B Hematology, pathology, and genetics

B.4020 Analysis of specific tests

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Nov 27, 2020

Nov 27, 2025