BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Endorectal balloon

    Reg #: 3006948745 · FEI: 3006948745 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    QLRAD
    Registration Number
    3006948745
    FEI Number
    3006948745
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Damsluisweg 6
    City
    Almere Flevoland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K180478

    Owner / Operator

    Firm Name
    QLRAD International Ltd.
    Operator Number
    10025073
    Address
    Damsluisweg 6
    City
    Almere
    State
    Flevoland
    Postal Code
    1332 EC
    Country
    NL
    Correspondent
    Arjen Winkel

    US Agent

    Business Name
    QLRAD Inc
    Contact Name
    EA Winkel Winkel
    Address
    80 SW 8th Street, ste 2000
    City
    Miami
    State
    FL
    ZIP
    33130
    Country
    US
    Email
    [email protected]
    Phone
    305 4378550

    Products

    Device Name Product Code
    Prostate Immobilizer Rectal Balloon PCT

    Proprietary Names

    Endorectal balloon

    Establishment Types

    Manufacture Medical Device