BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Softclix

    Reg #: 3007963752 · FEI: 3007963752 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BALDA MEDICAL GmbH
    Registration Number
    3007963752
    FEI Number
    3007963752
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bergkirchener Strasse 228, -
    City
    Bad Oeynhausen North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K214022

    Owner / Operator

    Firm Name
    Balda Medical GmbH
    Operator Number
    10030599
    Address
    Bergkirchener Strasse 228, -
    City
    Bad Oeynhausen
    State
    North Rhine-Westphalia
    Postal Code
    32549
    Country
    DE
    Correspondent
    Julia Dohm

    US Agent

    Business Name
    Balda C. Brewer, INC
    Contact Name
    Prajesh Patel
    Address
    4501 East Wall Street, -
    City
    Ontario
    State
    CA
    ZIP
    91761
    Country
    US
    Email
    [email protected]
    Phone
    630 8625485 ext. 0

    Products

    Device Name Product Code
    Multiple Use Blood Lancet For Single Patient Use Only QRL

    Proprietary Names

    Softclix

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)