Taiwan FDA registration 7f6950473583cc60aef1e279284447f4

“EUROIMMUN” EUROLINE Paraneoplastic Neurologic Syndromes 12 Ag (IgG)

TW: “歐蒙” 免疫膜條法副腫瘤神經綜合症IgG抗體篩選12抗原試驗系統
Taiwan flagTaiwan·Risk Class 2·MD·EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·Registered Mar 26, 2019 – Mar 26, 2024Expired
Registration details
Analysis ID
7f6950473583cc60aef1e279284447f4
License Form
Ministry of Health Medical Device Import No. 032382
Customs Code
DHA05603238208
Company information
Manufacturer Country
Germany
Product details
Intended Use
This product must be used with EUROLineScan software for in vitro qualitative detection of IgG antibodies against 12 different antigens in human serum or plasma: Amphiphysin, CV2, PNMA2 (Ma2/Ta), Ri, Yo, Hu, recoverin, SOX1, titin, zic4, GAD65, Tr (DNER) to diagnose paraneoplastic neurological syndrome (PNS).
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 26, 2019
Expiry Date
Mar 26, 2024
About this record

Access comprehensive regulatory information for “EUROIMMUN” EUROLINE Paraneoplastic Neurologic Syndromes 12 Ag (IgG) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7f6950473583cc60aef1e279284447f4 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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