BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    V20 System With V-VR Handpiece , V30 System With V-VR Handpiece , V10 System With V-VR Handpiece

    Reg #: 3005695724 · FEI: 3005695724 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    VIORA LTD.
    Registration Number
    3005695724
    FEI Number
    3005695724
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Sagi 2000, Industrial Park
    City
    Migdal HaEmek Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K202247

    Owner / Operator

    Firm Name
    VIORA LTD.
    Operator Number
    9086237
    Address
    Sinclair Pharmaceuticals Limited, Eden House, Lakeside, Chester Business Park
    City
    Chester
    State
    Cheshire West and Chester
    Postal Code
    CH4 9QT
    Country
    GB

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Massager, Therapeutic, Electric ISA
    Massager, Vacuum, Radio Frequency Induced Heat PBX

    Proprietary Names

    V20 System With V-VR Handpiece , V30 System With V-VR Handpiece , V10 System With V-VR Handpiece

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device