BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Vinyl Patient Examination Gloves

    Reg #: 3002801783 · FEI: 3002801783 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FRANZ KALFF GMBH
    Registration Number
    3002801783
    FEI Number
    3002801783
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    85 Dechant-Wolfgarten-Strasse
    City
    Euskirchen North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K102161

    Owner / Operator

    Firm Name
    Franz Kalff Gmbh
    Operator Number
    10054680
    Address
    85 Dechant-Wolfgarten-Strasse
    City
    Euskirchen
    State
    North Rhine-Westphalia
    Postal Code
    53881
    Country
    DE
    Correspondent
    Christof Gehlen

    US Agent

    Business Name
    AJW Technology Consultants, Inc.
    Contact Name
    Jon Ward
    Address
    11705 Boyette Road, #503
    City
    Riverview
    State
    FL
    ZIP
    33569
    Country
    US
    Email
    [email protected]
    Phone
    813 6452855 ext. 104

    Products

    Device Name Product Code
    Vinyl Patient Examination Glove LYZ

    Proprietary Names

    Vinyl Patient Examination Gloves

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device