BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    TempoCem AM NE Intro USA

    Reg #: 8044164 · FEI: 3004150030 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
    Registration Number
    8044164
    FEI Number
    3004150030
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ELBGAUSTRASSE 248
    City
    HAMBURG
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K970774

    Owner / Operator

    Firm Name
    DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
    Operator Number
    9005969
    Address
    ELBGAUSTRASSE 248, --
    City
    HAMBURG
    State
    DE-HH
    Postal Code
    D-22547
    Country
    DE

    US Agent

    Business Name
    Delphi Medical Device Consulting, Inc.
    Contact Name
    Pamela Papineau
    Address
    5 WHITCOMB AVENUE
    City
    Ayer
    State
    MA
    ZIP
    01432
    Country
    US
    Email
    [email protected]
    Phone
    978 7588322

    Products

    Device Name Product Code
    Cement, Dental EMA

    Proprietary Names

    TempoCem AM NE Intro USA TempoCem AM NE Refill 1+40 USA TEMPOCEM NE SMARTMIX USA

    Establishment Types

    Manufacture Medical Device