Taiwan FDA registration 5e93117cb8417930bee2cdac56f35cf3
“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
Taiwan·Risk Class 2·MD·EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·Registered Aug 02, 2018 – Aug 02, 2028ActiveRegistration details
- Analysis ID
- 5e93117cb8417930bee2cdac56f35cf3
- License Form
- Ministry of Health Medical Device Import No. 031345
- Customs Code
- DHA05603134500
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 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.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5100 Antinuclear antibody immunoassay system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 02, 2018
- Expiry Date
- Aug 02, 2028
About this record
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).
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