BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Radiance Ultra 55" ZeroWire Embedded

    Reg #: 3014991167 · FEI: 3014991167 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NDS Surgical Imaging, LLC
    Registration Number
    3014991167
    FEI Number
    3014991167
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Alte Poststrabe 11
    City
    Ludwigsstadt Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K161228

    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
    Sofia - Panagou

    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

    Proprietary Names

    Radiance Ultra 55" ZeroWire Embedded Radiance Ultra Series ZeroWire Embedded Radiance Ultra 27" ZeroWire Embedded Radiance Ultra 32" ZeroWire Embedded Radiance Ultra 24" ZeroWire Embedded

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)