BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Endo-SPONGE Pump

    Reg #: 3006581122 · FEI: 3006581122 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MEDITOP BV
    Registration Number
    3006581122
    FEI Number
    3006581122
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Vlasakker 22
    City
    Montfoort Utrecht
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K082311

    Owner / Operator

    Firm Name
    MediTop BV
    Operator Number
    10027208
    Address
    Vlasakker 22
    City
    Montfoort
    State
    Utrecht
    Postal Code
    3417XT
    Country
    NL
    Correspondent
    Theo Heiligenberg, v/d

    US Agent

    Business Name
    Clear Choice Therapeutics, Inc.
    Contact Name
    Bret Batchelder
    Address
    1053 E Whitaker Mill Rd Ste 145
    City
    Raleigh
    State
    NC
    ZIP
    27604
    Country
    US
    Email
    [email protected]
    Phone
    919 3451836

    Products

    Device Name Product Code
    Negative Pressure Wound Therapy Powered Suction Pump OMP

    Proprietary Names

    Endo-SPONGE Pump Exsudex

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device