BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH

    Reg #: 9615100 · FEI: 3001019699 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    1

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    Registration Details

    Registration Name
    ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH
    Registration Number
    9615100
    FEI Number
    3001019699
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    FABRIKSTRASSE 30
    City
    GROSSPOSTWITZ Saxony
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K142786

    Owner / Operator

    Firm Name
    Ontex Mexico Operations S.A de C.V
    Operator Number
    9036701
    Address
    Calle Doce Norte 105, Ciudad Industrial
    City
    Tijuana
    State
    Baja California
    Postal Code
    22444
    Country
    MX
    Correspondent
    Cecilia Guadalupe Jimenez Rodriguez

    US Agent

    Business Name
    Valor Brands LLC
    Contact Name
    Kyna Smith
    Address
    5900 Windward Parkway, Suite100
    City
    Alpharetta
    State
    GA
    ZIP
    30005
    Country
    US
    Email
    [email protected]
    Phone
    770 3469250

    Products

    Device Name Product Code
    Tampon, Menstrual, Unscented HEB

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)