BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    BREAS MEDICAL AB

    Reg #: 9617566 · FEI: 3003244771 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    10
    Establishment Types
    3
    Classifications
    12

    Registration Details

    Registration Name
    BREAS MEDICAL AB
    Registration Number
    9617566
    FEI Number
    3003244771
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    FORETAGSVAGEN 1
    City
    MOLNLYCKE Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K193586

    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
    Ramsey Lancaster
    Address
    16 Esquire Rd
    City
    N Billerica
    State
    MA
    ZIP
    01862
    Country
    US
    Email
    [email protected]
    Phone
    434 2561049

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK
    Oximeter DQA
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Continuous, Ventilator, Home Use NOU
    Sv70 Ventilator MNT
    Stand, Infusion FOX
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Ventilator, Continuous, Non-Life-Supporting MNS
    Accessory To Continuous Ventilator (Respirator) MOD
    Device, Positive Pressure Breathing, Intermittent NHJ

    Proprietary Names

    Vivo 45 LS Vivo 3 Vivo 65 Ventilator Trolley Single Patient Breathing Hose, Breathing Therapy Equipment Patient Circuit, Single Limb with Leakage Port, Disposable, B T-Piece US Vivo 1, Vivo 2 EveryWare Clearo Patient Circuit Americas Clearo

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device