BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MedFact Engineering GmbH

    Reg #: 3008497357 · FEI: 3008497357 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    MedFact Engineering GmbH
    Registration Number
    3008497357
    FEI Number
    3008497357
    Status
    Active
    Expiry Year
    2026
    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, Ultrasound, Intravascular OBJ
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Retractor GAD

    Proprietary Names

    7F PV Catheters 4F PV Catheters EasyMap MAP EProC Esophageal Retractor

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device