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“EUROIMMUN” EUROLINE Coeliac Disease Profile (IgA) - Taiwan Registration f7d3b28f60bcdbf6305e29434f26ac44

Access comprehensive regulatory information for “EUROIMMUN” EUROLINE Coeliac Disease Profile (IgA) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f7d3b28f60bcdbf6305e29434f26ac44 and manufactured by EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG. The authorized representative in Taiwan is EUROIMMUN (SOUTH EAST ASIA) PTE. LTD. TAIWAN BRANCH (SINGAPORE).

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f7d3b28f60bcdbf6305e29434f26ac44
Registration Details
Taiwan FDA Registration: f7d3b28f60bcdbf6305e29434f26ac44
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Device Details

“EUROIMMUN” EUROLINE Coeliac Disease Profile (IgA)
TW: “歐蒙” 免疫膜條法抗乳糜瀉抗體譜IgA檢測試劑
Risk Class 2
MD

Registration Details

f7d3b28f60bcdbf6305e29434f26ac44

Ministry of Health Medical Device Import No. 033500

DHA05603350006

Product Details

This product is used for in vitro qualitative detection of anti-tissue glutaminetransferase (tTG) and gliadin (GAF-3X, gliadin-like fusion peptide) immunoglobulin IgA in human serum or plasma for the diagnosis of gluten-sensitive enteropathy and Dunchenne dermatitis.

C Clinical Chemistry and Clinical Toxicology

C5660 Multiple autologous antibody immunoassay system

Imported from abroad

Dates and Status

Jul 01, 2020

Jul 01, 2025