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“EUROIMMUN” EUROLINE Anti-MPO, -PR3 and -GBM (IgG) - Taiwan Registration bdea8f3bc03c84435483ad2c7596c21c

Access comprehensive regulatory information for “EUROIMMUN” EUROLINE Anti-MPO, -PR3 and -GBM (IgG) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number bdea8f3bc03c84435483ad2c7596c21c 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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bdea8f3bc03c84435483ad2c7596c21c
Registration Details
Taiwan FDA Registration: bdea8f3bc03c84435483ad2c7596c21c
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Device Details

“EUROIMMUN” EUROLINE Anti-MPO, -PR3 and -GBM (IgG)
TW: “歐蒙” 免疫膜條法抗MPO, PR3, GBM IgG抗體篩選免疫試驗系統
Risk Class 2
MD

Registration Details

bdea8f3bc03c84435483ad2c7596c21c

Ministry of Health Medical Device Import No. 031404

DHA05603140400

Product Details

This product is used for in vitro qualitative detection of anti-myeloperoxidase (MPO), protease 3 (PR3), glomerular basement membrane (GBM) antibody immunoglobulin G (IgG) in human serum or plasma.

C Immunology and microbiology devices

C5660 Multiple autologous antibody immunoassay system

Imported from abroad

Dates and Status

Aug 08, 2018

Aug 08, 2028