BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    ELDON BIOLOGICALS A/S

    Reg #: 3003783142 · FEI: 3003783142 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ELDON BIOLOGICALS A/S
    Registration Number
    3003783142
    FEI Number
    3003783142
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    SANDTOFTEN 10
    City
    GENTOFTE Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K790282

    Owner / Operator

    Firm Name
    ELDON BIOLOGICALS A/S
    Operator Number
    9031770
    Address
    SANDTOFTEN 10, --
    City
    GENTOFTE
    State
    Hovedstaden
    Postal Code
    DK-2820
    Country
    DK

    US Agent

    Business Name
    Strategic Sales and Marketing LLC dba UnitedPharma
    Contact Name
    Yariv Sivan
    Address
    15815 Burdette Ct
    City
    Milton
    State
    GA
    ZIP
    30004
    Country
    US
    Email
    [email protected]
    Phone
    404 3285144 ext. 144

    Products

    Device Name Product Code
    System, Test, Automated Blood Grouping And Antibody KSZ

    Proprietary Names

    ONE MAN KIT OKA 2511-1 EldonCard DOCTOR'S KIT DKS RhD-25 ELDONBOX 2521-100 ELDON SCHOOL KIT SK 2511-30 ELDON MILITARY KIT MKA 2521-25 ELDON BAG 2521-25 ELDON SCHOOL KIT SKA 2521-25 ELDON SCHOOL KIT SKA 2511-30 ELDONBOX 2511-100 ELDON HOME KIT HKA 2511-1

    Establishment Types

    Manufacture Medical Device