BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Neutron

    Reg #: 9617594 · FEI: 3003807466 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    ICU MEDICAL DE MEXICO, S. de R.L. de C.V.
    Registration Number
    9617594
    FEI Number
    3003807466
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Avenida Cuarzo No. 250, Colonia Rancho Santa Clara, Maneadero
    City
    ENSENADA, Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K100434

    Owner / Operator

    Firm Name
    ICU MEDICAL, INC.
    Operator Number
    2025816
    Address
    951 Calle Amanecer, --
    City
    San Clemente
    State
    CA
    Postal Code
    92673
    Country
    US
    Correspondent
    Michelle Doherty

    US Agent

    Business Name
    ICU MEDICAL, INC.
    Contact Name
    Michelle Doherty
    Address
    951 Calle Amanecer
    City
    San Clemente
    State
    CA
    ZIP
    92673
    Country
    US
    Email
    [email protected]
    Phone
    949 3706562

    Products

    Device Name Product Code
    Accessories, Catheter KGZ
    Set, Administration, Intravascular FPA

    Proprietary Names

    Neutron

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device