BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Z2

    Reg #: 3010817335 · FEI: 3010817335 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BREAS MEDICAL, INC.
    Registration Number
    3010817335
    FEI Number
    3010817335
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    16 Esquire Road
    City
    N Billerica
    State
    MA
    ZIP
    01862
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140929

    Owner / Operator

    Firm Name
    BREAS MEDICAL, INC.
    Operator Number
    10046641
    Address
    16 Esquire Road
    City
    N Billerica
    State
    MA
    Postal Code
    01862
    Country
    US

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    Z2

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device