BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Freezpen

    Reg #: 3004753330 · FEI: 3004753330 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    H&O EQUIPMENTS NV/Clinic6
    Registration Number
    3004753330
    FEI Number
    3004753330
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rue des Journaliers 1
    City
    Ghislenghien Hainaut
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K024009

    Owner / Operator

    Firm Name
    H&O Equipments NV/Clinic6
    Operator Number
    10027912
    Address
    Rue des Journaliers, 1
    City
    Ghislenghien
    State
    BE-NOTA
    Postal Code
    7822
    Country
    BE
    Correspondent
    Mindy McCann

    US Agent

    Business Name
    Qserve Group US Inc.
    Contact Name
    Mindy McCann
    Address
    350 S Main Street, Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Unit, Cryosurgical, Accessories GEH

    Proprietary Names

    Freezpen CryoProbe o CryoProbe X CryoPen c N2O Cartridges CryoProbe m CryoProbe C CryoProbe CryoProbe b CryoProbe Touch CryoProbe XP CryoProbe X+ CryoProbe B+ CryoProbe O+ CryroProbe XPS CryoProbe M Freezpen 8g Freezpen 16g Freezpen 35g

    Establishment Types

    Manufacture Medical Device