BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HELMED® AUTOMATED IFA PROCESSOR

    DI: 04250289512565 · Model: REF.HEL-1000 · Aesku.Diagnostics GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HELMED® AUTOMATED IFA PROCESSOR
    Primary DI
    04250289512565
    Version / Model
    REF.HEL-1000
    Catalog Number
    REF.HEL-1000
    Company Name
    Aesku.Diagnostics GmbH & Co. KG
    Labeler DUNS
    341714388
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-25
    Public Version
    1
    Public Version Date
    2023-07-03
    Public Version Status
    New
    Public Device Record Key
    bd06d19b-d516-4986-bffe-d74031a1f4ab

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JQW Station, Pipetting And Diluting, For Clinical Use

    GMDN Terms

    Code Name
    57871 Specimen processing instrument IVD

    Identifiers

    Type ID
    Primary 04250289512565