BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    ECGenius System

    Reg #: 3017401510 · FEI: 3017401510 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CATHVISION APS
    Registration Number
    3017401510
    FEI Number
    3017401510
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lygten 37 st. th.
    City
    Copenhagen NV Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K223787

    Owner / Operator

    Firm Name
    CathVision ApS
    Operator Number
    10085183
    Address
    Lygten 37 st. th.
    City
    Copenhagen NV
    State
    DK-NOTA
    Postal Code
    2400
    Country
    DK

    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
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    ECGenius System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device