Taiwan FDA registration 4bbc1c05694d8a8279e8d7d634c2ea66
“EUROIMMUN” IIFT: HEp-20-10
TW: “歐蒙” 免疫螢光法抗核抗體IgG檢測試劑
Taiwan·Risk Class 2·MD·EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·Registered Mar 07, 2018 – Mar 07, 2028ActiveRegistration details
- Analysis ID
- 4bbc1c05694d8a8279e8d7d634c2ea66
- License Form
- Ministry of Health Medical Device Import No. 030516
- Customs Code
- DHA05603051606
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 by immunofluorescence method for in vitro qualitative or semi-quantitative detection of antinuclear antibodies 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
- Mar 07, 2018
- Expiry Date
- Mar 07, 2028
About this record
Access comprehensive regulatory information for “EUROIMMUN” IIFT: HEp-20-10 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4bbc1c05694d8a8279e8d7d634c2ea66 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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