BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Calibrator, primary

    Reg #: 3009518015 · FEI: 3009518015 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    7051395 CANADA INC DBA HTA DIRECT SOURCING
    Registration Number
    3009518015
    FEI Number
    3009518015
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    102 West Service Road, Unit 047
    City
    Champlain
    State
    NY
    ZIP
    12919
    Country
    US

    Regulatory Submissions

    510(k) Number
    K982250

    Owner / Operator

    Firm Name
    7051395 Canada Inc Dba HTA Direct Sourcing
    Operator Number
    10084602
    Address
    102 West Service Road, Unit 1047
    City
    Champlain
    State
    NY
    Postal Code
    12919
    Country
    US

    Products

    Device Name Product Code
    Calibrator, Primary JIS
    Radioimmunoassay, Free Thyroxine CEC

    Proprietary Names

    Calibrator, primary 100566RADIOIMMUNOASSAY, FREE THYROXINE

    Establishment Types

    Repack or Relabel Medical Device