BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    TCL3 Motion Tracking System

    Reg #: 3019844073 · FEI: 3019844073 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    TracInnovations A/S
    Registration Number
    3019844073
    FEI Number
    3019844073
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Brydehusvej 13
    City
    Ballerup Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K221785

    Owner / Operator

    Firm Name
    TracInnovations A/S
    Operator Number
    10082007
    Address
    Brydehusvej 13
    City
    Ballerup
    State
    Hovedstaden
    Postal Code
    2750
    Country
    DK
    Correspondent
    Barbara Kovacs

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    TCL3 Motion Tracking System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device