BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Inventeur, LLC

    Reg #: 3009545593 · FEI: 3009545593 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    FCM SMART CENTER GROUP
    Registration Number
    3009545593
    FEI Number
    3009545593
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1515 Gunn Hwy
    City
    Odessa
    State
    FL
    ZIP
    33556
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240937

    Owner / Operator

    Firm Name
    Caribbean Custom Mold Inc
    Operator Number
    10047366
    Address
    Zona Franca Las Americas, Aut Las Americas KM.22
    City
    Santo Domingo
    State
    DO-32
    Postal Code
    11606
    Country
    DO
    Correspondent
    Randolph Geronimo

    Products

    Device Name Product Code
    Endoscopic Bite Block MNK
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Cannula, Nasal, Oxygen CAT

    Proprietary Names

    Inventeur, LLC

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)