Taiwan FDA registration b691764decd90ddc4c13e60f7b131cd3
“EUROIMMUN”Anti-Cardiolipin ELISA (IgG)
TW: “歐蒙”免疫酵素法抗心磷脂抗體IgG抗體試劑
Taiwan·Risk Class 2·MD·EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·Registered Apr 02, 2019 – Apr 02, 2024ExpiredRegistration details
- Analysis ID
- b691764decd90ddc4c13e60f7b131cd3
- License Form
- Ministry of Health Medical Device Import No. 032396
- Customs Code
- DHA05603239606
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 can quantify or semi-quantitatively detect anticardiolipin antibody 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
- Apr 02, 2019
- Expiry Date
- Apr 02, 2024
About this record
Access comprehensive regulatory information for “EUROIMMUN”Anti-Cardiolipin 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 b691764decd90ddc4c13e60f7b131cd3 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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