BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    TEC COM MEDIZINTECHNIK GMBH

    Reg #: 3016507522 · FEI: 3016507522 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    TEC COM MEDIZINTECHNIK GMBH
    Registration Number
    3016507522
    FEI Number
    3016507522
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Am Kruemmling 1
    City
    Kabelsketal Saxony-Anhalt
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K140078

    Owner / Operator

    Firm Name
    Tec Com Medizintechnik GmbH
    Operator Number
    10061013
    Address
    Am Kruemmling 1
    City
    Kabelsketal
    State
    Saxony-Anhalt
    Postal Code
    06184
    Country
    DE
    Correspondent
    Sebastian Dr. Ebert

    US Agent

    Business Name
    International Biomedical
    Contact Name
    Amy Piper
    Address
    8206 Cross Park Dr
    City
    Austin
    State
    TX
    ZIP
    78754
    Country
    US
    Email
    [email protected]
    Phone
    512 8730033

    Products

    Device Name Product Code
    System, Thermal Regulating DWJ
    Mattress, Water, Temperature Regulated FOH
    Bedding, Disposable, Medical KME

    Proprietary Names

    TECOtherm NEO TECOtherm Wrabbit M TECOtherm Wrabbit L TECOtherm Wrabbit S

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198