BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Immobilization and Biopsy System for OBC Breast Coil Invivo

    Reg #: 3004929307 · FEI: 3004929307 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NORAS MRI products GMBH
    Registration Number
    3004929307
    FEI Number
    3004929307
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LEIBNIZSTRASSE 4
    City
    HOECHBERG Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K010570

    Owner / Operator

    Firm Name
    NORAS MRI products GmbH
    Operator Number
    9071737
    Address
    LEIBNIZSTRASSE 4, --
    City
    HOECHBERG
    State
    DE-NOTA
    Postal Code
    97204
    Country
    DE
    Correspondent
    Manuel - NORAS

    US Agent

    Business Name
    MEDTEC LLC
    Contact Name
    Alena Newgren
    Address
    1401 8th St Se
    City
    Orange City
    State
    IA
    ZIP
    51041
    Country
    US
    Email
    [email protected]
    Phone
    319 2486650

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    Immobilization and Biopsy System for OBC Breast Coil Invivo Coil MR BI160 MR BI160-GE Immobilization and Biopsy System for GE High Density Mamma

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device