BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    ThermaSolutions Europe B.V.

    Reg #: 3006986257 · FEI: 3006986257 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    ThermaSolutions Europe B.V.
    Registration Number
    3006986257
    FEI Number
    3006986257
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Takkebijsters 41
    City
    Breda Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K131583

    Owner / Operator

    Firm Name
    THERMASOLUTIONS LLC.
    Operator Number
    9082263
    Address
    1889 Buerkle Road
    City
    White Bear Lake
    State
    MN
    Postal Code
    55110
    Country
    US
    Correspondent
    Rhea Johny

    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
    Catheter, Irrigation GBX

    Proprietary Names

    ThermoChem HT-2000 ThermoChem HT-2500 ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) FLW-0111 Long Lasso Tubing PAK-0112 Inflow and Outflow Tubing Pack FLW-0010 Lasso Tubing FLW-0120 Inflow Tubing THERMOCHEM HT-1000

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device