BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    ThermaChem HT2000

    Reg #: 3014377913 · FEI: 3014377913 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RELITECH B.V.
    Registration Number
    3014377913
    FEI Number
    3014377913
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    van Siburgstraat 34
    City
    Nijkerk Gelderland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K131583

    Owner / Operator

    Firm Name
    Relitech B.V.
    Operator Number
    10057338
    Address
    van Siburgstraat 34
    City
    Nijkerk
    State
    Gelderland
    Postal Code
    nl-3863 HW
    Country
    NL
    Correspondent
    Jack Musters

    US Agent

    Business Name
    THERMASOLUTIONS, LLC
    Contact Name
    Gregg Giza
    Address
    1889 Buerkle Road, --
    City
    White Bear Lake
    State
    MN
    ZIP
    55110
    Country
    US
    Email
    [email protected]
    Phone
    651 2093900

    Products

    Device Name Product Code
    Warmer, Peritoneal Dialysate MLW

    Proprietary Names

    ThermaChem HT2000

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)