BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    VWSP-450F

    Reg #: 3011213495 · FEI: 3011213495 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INOVYTEC MEDICAL SOLUTIONS LTD.
    Registration Number
    3011213495
    FEI Number
    3011213495
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 HaTidhar St., Industrial Zone
    City
    Raanana Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K202970

    Owner / Operator

    Firm Name
    Inovytec Medical Solutions Ltd.
    Operator Number
    10047253
    Address
    5 HaTidhar St., Industrial Zone
    City
    Raanana
    State
    IL-NOTA
    Postal Code
    4366507
    Country
    IL
    Correspondent
    Udi Kantor

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    Matt Dryden
    Address
    131 bay point dr ne
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    VWSP-450F VWSP-900 VWSP-810 VWSP-420 VWSP-430 VWSP-100 VWSP-550F VWSP-304 VWSP-100MR Ventway Sparrow VWSP-580 VWSP-900 MR VWSP-1450F VWSP-1550F

    Establishment Types

    Manufacture Medical Device