BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    NORAS MRI products GMBH

    Reg #: 3004929307 · FEI: 3004929307 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    42
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    NORAS MRI products GMBH
    Registration Number
    3004929307
    FEI Number
    3004929307
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LEIBNIZSTRASSE 4
    City
    HOECHBERG Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K093693

    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
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Imaging LNH
    Holder, Head, Neurosurgical (Skull Clamp) HBL
    Guide, Needle, Surgical GDF

    Proprietary Names

    OR Head Coil 3T 114557 Top Array OR Head Coil 3T 114558 Bottom Array OR Head Coil 1.5T 111921 Top Array OR Head Coil 1.5T 111922 Bottom Array OR Head Holder SI7000-MQ OR Head Holder 113066 OR Head Coil 1.5T 7130-PH OR Head Coil 3T 7230-PH OR HEAD COIL 1.5 T OR Head Coil 1.5T 114491 Bottom Array OR Head Coil 1.5T 114497 Top Array SI7130 Immobilization and Biopsy System for OBC Breast Coil Invivo MR BI160-GE MR BI160 Immobilization and Biopsy System for GE High Density Mamma Coil NORAS OR Head Holder Flexibility 114464 OR Head Holder SI7000 OR Head Holder SI7300 OR Head Holder 113056 iLoop Interventional Coil BI160-O BI160-CC BI160-PA Breast Immobilization and Biopsy Device Breast BI 7 MR Coil 1,5T 4 Ch BI Breast MR Coil Kit 1.5T MR-BI320-PA 1.5T OR Head Coil 3T 113719 Bottom Array OR Head Coil 3T 112893 Top Array SI7230 OR Head Coil 3T 4 Ch BI Breast MR Coil Kit 3T MR-BI320-PA 3T Breast BI 7 MR Coil Mammavention 3T Encompass 15 Channel Head Coil, 3T LUCY Uni-Lift Prostate Intervention Device Breast BI 7 MR Coil Set 1.5T Breast BI Coil Set 0.55T Breast BI 7 MR Coil Set 3T

    Establishment Types

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