Taiwan FDA registration 8b62ed473f5db2f8fb3f956608af2ffc
“EUROIMMUN” EUROLINE Liver Profile (IgG)
TW: “歐蒙” 免疫膜條法肝臟系列抗體IgG篩選免疫試驗系統
Registration details
- Analysis ID
- 8b62ed473f5db2f8fb3f956608af2ffc
- License Form
- Ministry of Health Medical Device Import No. 030513
- Customs Code
- DHA05603051300
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 the qualitative detection of anti-AMA-M2, LKM-1, LC-1 and SLA/LP and other different antigen IgG antibodies 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
- Mar 02, 2018
- Expiry Date
- Mar 02, 2028
About this record
Access comprehensive regulatory information for “EUROIMMUN” EUROLINE Liver Profile (IgG) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8b62ed473f5db2f8fb3f956608af2ffc 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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