BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    PowerLoc Safety Infusion Set

    Reg #: 3008537309 · FEI: 3008537309 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Grupo American Industries, S.A. De C.V
    Registration Number
    3008537309
    FEI Number
    3008537309
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    V. SANTIAGO TRONCOSO #281, INTERIOR 1 COLONIA PAQUIME
    City
    Ciudad Juarez Chihuahua
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K060812

    Owner / Operator

    Firm Name
    FOREFRONT MEDICAL AMERICAS PTE. LTD.
    Operator Number
    10090828
    Address
    35 Joo Koon Circle
    City
    Singapore
    State
    South West
    Postal Code
    629110
    Country
    SG
    Correspondent
    Wil Seah

    Products

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

    Proprietary Names

    PowerLoc Safety Infusion Set

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)