BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Vivo 3

    Reg #: 9617566 · FEI: 3003244771 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BREAS MEDICAL AB
    Registration Number
    9617566
    FEI Number
    3003244771
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    FORETAGSVAGEN 1
    City
    MOLNLYCKE Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K240779

    Owner / Operator

    Firm Name
    Breas Medical
    Operator Number
    10046282
    Address
    Foretagsvagen 1
    City
    MOLNLYCKE
    State
    Vastra Gotaland
    Postal Code
    SE43533
    Country
    SE

    US Agent

    Business Name
    Breas Medical, Inc.
    Contact Name
    Patricia Clark
    Address
    16 Esquire Road
    City
    N Billerica
    State
    MA
    ZIP
    01862
    Country
    US
    Email
    [email protected]
    Phone
    617 2865509

    Products

    Device Name Product Code
    Ventilator, Continuous, Minimal Ventilatory Support, Facility Use MNT
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT

    Proprietary Names

    Vivo 3

    Establishment Types

    Manufacture Medical Device