BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Asian Profile AD Protraction Facemask

    Reg #: 3003948427 · FEI: 3003948427 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORTOSIM, S.A. DE C.V.
    Registration Number
    3003948427
    FEI Number
    3003948427
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CONVENTO DE ACTOPAN No. 13-A
    City
    TLALNEPANTLA Mexico
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K923556

    Owner / Operator

    Firm Name
    FERNANDO MORALES GARFIAS
    Operator Number
    9052068
    Address
    CONVENTO DE ACTOPAN #13-A, --
    City
    TLALNEPANTLA, EDO.DE MEX.
    State
    MX-NOTA
    Postal Code
    54050
    Country
    MX

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Headgear, Extraoral, Orthodontic DZB

    Proprietary Names

    Asian Profile AD Protraction Facemask AD Protraction Facemask

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)