Taiwan FDA registration bdea8f3bc03c84435483ad2c7596c21c
“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
Taiwan·Risk Class 2·MD·EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·Registered Aug 08, 2018 – Aug 08, 2028ActiveRegistration details
- Analysis ID
- bdea8f3bc03c84435483ad2c7596c21c
- License Form
- Ministry of Health Medical Device Import No. 031404
- Customs Code
- DHA05603140400
Company information
- Manufacturer
- EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
- Manufacturer Country
- Germany
- Authorized Representative
- EUROIMMUN (SOUTH EAST ASIA) PTE. LTD. TAIWAN BRANCH (SINGAPORE)
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5660 Multiple autologous antibody immunoassay system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 08, 2018
- Expiry Date
- Aug 08, 2028
About this record
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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