Taiwan FDA registration 8e8a7d942a748e4f8de074b0010f5c65

"Siemens" hepatitis A antibody test set

TW: “西門子” A型肝炎抗體檢驗試劑組
Taiwan flagTaiwan·Risk Class 3·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Registered Apr 12, 2022 – Apr 12, 2027Active
Registration details
Analysis ID
8e8a7d942a748e4f8de074b0010f5c65
Customs Code
DHA05603523701
Company information
Manufacturer Country
United States
Authorized Representative
SIEMENS HEALTHCARE LIMITED
Product details
Intended Use
This product is used for in vitro diagnostic use with Atellica IM Analyzer for the quantitative determination of total antibodies to hepatitis A virus in human serum and plasma (EDTA, lithium heparin and sodium heparin).
Product Type (Level 1)
B Hematology, pathology, and genetics
Product Type (Level 2)
B.4020 Analysis of specific tests
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Apr 12, 2022
Expiry Date
Apr 12, 2027
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About this record

Access comprehensive regulatory information for "Siemens" hepatitis A antibody test set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 8e8a7d942a748e4f8de074b0010f5c65 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including SIEMENS HEALTHCARE DIAGNOSTICS INC., and 1 recent registrations in the same category. 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.

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