BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    NDS Surgical Imaging, LLC

    Reg #: 3014991167 · FEI: 3014991167 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    37
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    NDS Surgical Imaging, LLC
    Registration Number
    3014991167
    FEI Number
    3014991167
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Alte Poststrabe 11
    City
    Ludwigsstadt Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K032638

    Owner / Operator

    Firm Name
    NDS Surgical Imaging, LLC
    Operator Number
    9045073
    Address
    Salzufer 8, --
    City
    Berlin
    State
    DE-BE
    Postal Code
    10587
    Country
    DE
    Correspondent
    Silke - Lucht

    US Agent

    Business Name
    NDS SURGICAL IMAGING, LLC
    Contact Name
    Michael Reents
    Address
    100 Paramount Drive, Suite 101
    City
    Sarasota
    State
    FL
    ZIP
    34232
    Country
    US
    Email
    [email protected]
    Phone
    941 7462413

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ
    System, Image Processing, Radiological LLZ
    Device, Digital Image Storage, Radiological LMB
    Camera, Surgical And Accessories KQM
    System, Digital Image Communications, Radiological LMD

    Proprietary Names

    RADIANCE ULTRA 32" 4K ZEROWIRE DUO E3 S3c S3 C3, C3i E3cHB E3c ZeroWire Evolution4K C5i E5 C5 ZeroWire or ZeroWire G2 E4c ZeroWire Plus ZeroWire Ultra Radiance Ultra 24" ZeroWire Embedded Radiance Ultra Series ZeroWire Embedded Radiance Ultra 32" ZeroWire Embedded Radiance Ultra 55" ZeroWire Embedded Radiance Ultra 27" ZeroWire Embedded E2c E2cHB E2 S2c ND-Cam GX5MP Vital Screen LifeVue ENDOVUE RADIANCE Evolution family ExpandOR ND3, Connect OR ScaleOR ConductOR

    Establishment Types

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