BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Sterile container

    Reg #: 3017155536 · FEI: 3017155536 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SK PHARMA LOGISTICS GMBH
    Registration Number
    3017155536
    FEI Number
    3017155536
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Remusweg 8
    City
    Bielefeld North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K123234

    Owner / Operator

    Firm Name
    SK Pharma Logistics GmbH
    Operator Number
    10091163
    Address
    Remusweg 8
    City
    Bielefeld
    State
    North Rhine-Westphalia
    Postal Code
    33729
    Country
    DE
    Correspondent
    Lars Wiese

    US Agent

    Business Name
    confinis USA Inc.
    Contact Name
    Alfred Lerch
    Address
    600 Park Offices Drive Suite 300, Unit #50
    City
    Durham
    State
    NC
    ZIP
    27709
    Country
    US
    Email
    [email protected]
    Phone
    910 2289391

    Products

    Device Name Product Code
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT

    Proprietary Names

    Sterile container

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device