BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    H12+ Holter Recorder

    Reg #: 3006087789 · FEI: 3006087789 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V.
    Registration Number
    3006087789
    FEI Number
    3006087789
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CALLE EMILIO FLORES 2471-A and 2469-C, COL. CANON DEL PADRE
    City
    TIJUANA Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K050896

    Owner / Operator

    Firm Name
    BAXTER HEALTHCARE CORPORATION
    Operator Number
    1417572
    Address
    One Baxter Parkway
    City
    Deerfield
    State
    IL
    Postal Code
    60015
    Country
    US
    Correspondent
    Maha Nolasco

    US Agent

    Business Name
    BAXTER HEALTHCARE CORPORATION
    Contact Name
    Maha Nolasco
    Address
    25212 W. IL Route 120, RLT-04
    City
    Round Lake
    State
    IL
    ZIP
    60073
    Country
    US
    Email
    [email protected]
    Phone
    224 2706181

    Products

    Device Name Product Code
    Recorder, Magnetic Tape, Medical DSH

    Proprietary Names

    H12+ Holter Recorder

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)