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“EUROIMMUN” EUROLINE Anti-ENA ProfilePlus 1 (IgG) - Taiwan Registration 5e93117cb8417930bee2cdac56f35cf3

Access comprehensive regulatory information for “EUROIMMUN” EUROLINE Anti-ENA ProfilePlus 1 (IgG) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5e93117cb8417930bee2cdac56f35cf3 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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5e93117cb8417930bee2cdac56f35cf3
Registration Details
Taiwan FDA Registration: 5e93117cb8417930bee2cdac56f35cf3
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Device Details

“EUROIMMUN” EUROLINE Anti-ENA ProfilePlus 1 (IgG)
TW: “歐蒙” 免疫膜條法抗核抗體譜IgG篩選免疫試驗系統1
Risk Class 2
MD

Registration Details

5e93117cb8417930bee2cdac56f35cf3

Ministry of Health Medical Device Import No. 031345

DHA05603134500

Product Details

This product is used for qualitative testing of 7 different autoantibodies such as nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Sc1-70 and Jo-1 in human serum or plasma.

C Immunology and microbiology devices

C5100 Antinuclear antibody immunoassay system

Imported from abroad

Dates and Status

Aug 02, 2018

Aug 02, 2028