Taiwan FDA registration 84df1076214ba9c6b3b64ed172611b31
“EUROIMMUN” EUROLINE ANA-Profile 1(IgG)
TW: “歐蒙” 免疫膜條法抗核抗體IgG免疫試驗系統1
Taiwan·Risk Class 2·MD·EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·Registered Dec 12, 2018 – Dec 12, 2028ActiveRegistration details
- Analysis ID
- 84df1076214ba9c6b3b64ed172611b31
- License Form
- Ministry of Health Medical Device Import No. 031963
- Customs Code
- DHA05603196300
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 12 different autoantibodies such as nRNP/Sm, Sm, SS-A (native), Ro-52, SS-B, Sc1-70, Jo-1, CENP B, dsDNA, nucleosomes, histones and ribosomal P-proteins 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
- Dec 12, 2018
- Expiry Date
- Dec 12, 2028
About this record
Access comprehensive regulatory information for “EUROIMMUN” EUROLINE ANA-Profile 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 84df1076214ba9c6b3b64ed172611b31 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