BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bayer1675 (SX) - Disposable MRI Kit with Check Valve

    Reg #: 3009882464 · FEI: 3009882464 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Synergy Health AST, LLC
    Registration Number
    3009882464
    FEI Number
    3009882464
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7225 N Noah Dr
    City
    Saxonburg
    State
    PA
    ZIP
    16056
    Country
    US

    Regulatory Submissions

    510(k) Number
    K980417

    Owner / Operator

    Firm Name
    Synergy Health AST, LLC
    Operator Number
    10028672
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    Bayer1675 (SX) - Disposable MRI Kit with Check Valve

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)