Pure Global

“EUROIMMUN” Anti-M2-3E ELISA (IgG) - Taiwan Registration f40ae5b565f884070963998839abbc7d

Access comprehensive regulatory information for “EUROIMMUN” Anti-M2-3E ELISA (IgG) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f40ae5b565f884070963998839abbc7d and manufactured by EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG. The authorized representative in Taiwan is EUROIMMUN (SOUTH EAST ASIA) PTE. LTD. TAIWAN BRANCH (SINGAPORE).

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
f40ae5b565f884070963998839abbc7d
Registration Details
Taiwan FDA Registration: f40ae5b565f884070963998839abbc7d
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Details

“EUROIMMUN” Anti-M2-3E ELISA (IgG)
TW: “歐蒙” 免疫酵素法抗粒線體M2 IgG抗體試劑
Risk Class 2
MD

Registration Details

f40ae5b565f884070963998839abbc7d

Ministry of Health Medical Device Import No. 031115

DHA05603111506

Product Details

This product is used for in vitro qualitative or semi-quantitative detection of anti-granular M2 IgG antibodies in human serum or plasma to assist in the diagnosis of primary biliary cirrhosis (PBC).

C Immunology and microbiology devices

C5090 Anti-granular antibody immunoassay system

Imported from abroad

Dates and Status

May 22, 2018

May 22, 2028