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    FDA Registration Active 🇩🇪 Germany

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    Reg #: 3008497357 · FEI: 3008497357 · Expires 2025
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    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MedFact Engineering GmbH
    Registration Number
    3008497357
    FEI Number
    3008497357
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hammerstr. 3
    City
    Loerrach Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K151139

    Owner / Operator

    Firm Name
    MEDFACT ENGINEERING GMBH
    Operator Number
    10045544
    Address
    Hammerstrasse 3
    City
    Loerrach
    State
    Baden-Wurttemberg
    Postal Code
    79540
    Country
    DE
    Correspondent
    JOERG REINHARDT

    US Agent

    Business Name
    Graematter, Inc
    Contact Name
    Melissa Walker
    Address
    225 W Crockett St
    City
    De Kalb
    State
    TX
    ZIP
    75559
    Country
    US
    Email
    [email protected]
    Phone
    636 4057498

    Products

    Device Name Product Code
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF

    Proprietary Names

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    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device