BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    PowerLoc Safety Infusion Set

    Reg #: 3009746061 · FEI: 3009746061 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Integra Biotechnical, SA de CV
    Registration Number
    3009746061
    FEI Number
    3009746061
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Privada Los Pinos #17030 Interior 15, 16, 17, Colonia Ninos Heroes Este, C.P, Ave. Via Rapida Poniente #16835 Interior 3, Centro Ind. Los Pinos II, Colonia Ninos Heroes Este, C.P.
    City
    Tijuana Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K060812

    Owner / Operator

    Firm Name
    Amphenol Critical Medical Technologies, LLC
    Operator Number
    9030406
    Address
    9586 Distribution Avenue, Suite F
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Lamont Rohde

    US Agent

    Business Name
    Amphenol Critical Medical Technologies, LLC
    Contact Name
    Lamont Rohde
    Address
    9586 Distribution Avenue, Suite F
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    602 7503539

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT

    Proprietary Names

    PowerLoc Safety Infusion Set

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)