Taiwan FDA registration a9139cd19ad74387220b5da6b67baa49
“EUROIMMUN”Anti-Cardiolipin ELISA (IgM)
TW: “歐蒙”免疫酵素法抗心磷脂抗體IgM抗體試劑
Taiwan·Risk Class 2·MD·EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·Registered Aug 07, 2019 – Aug 07, 2024ExpiredRegistration details
- Analysis ID
- a9139cd19ad74387220b5da6b67baa49
- License Form
- Ministry of Health Medical Device Import No. 032476
- Customs Code
- DHA05603247604
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 IgM in human serum or plasma. This product is used to diagnose antiphospholipid syndrome.
- 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 07, 2019
- Expiry Date
- Aug 07, 2024
About this record
Access comprehensive regulatory information for “EUROIMMUN”Anti-Cardiolipin ELISA (IgM) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a9139cd19ad74387220b5da6b67baa49 and manufactured by EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG. The authorized representative in Taiwan is EUROIMMUN (SOUTH EAST ASIA) PTE. LTD. TAIWAN BRANCH (SINGAPORE).
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices