BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PE – cup insert 0 ID = 2803439

    Reg #: 3002808022 · FEI: 3002808022 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ROSE GMBH FUER MEDIZINTECHNIK
    Registration Number
    3002808022
    FEI Number
    3002808022
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gottbillstrasse 25
    City
    Trier Rhineland-Palatinate
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K163577

    Owner / Operator

    Firm Name
    Rose GmbH fuer Medizintechnik
    Operator Number
    10042910
    Address
    Gottbillstrasse 25
    City
    Trier
    State
    Rhineland-Palatinate
    Postal Code
    54294
    Country
    DE
    Correspondent
    Thomas Rose

    US Agent

    Business Name
    German American Chamber of Commerce, Inc.
    Contact Name
    German American Chamber of Commerce, Inc. German American Ch
    Address
    80 Pine Street, 24th Floor
    City
    New York
    State
    NY
    ZIP
    10005
    Country
    US
    Email
    [email protected]
    Phone
    212 9748830

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    PE – cup insert 0 ID = 2803439 PE – cup insert 0 ID = 2803452 PE – cup insert 10 ID = 02803139 PE – cup insert 10 = 2803144 PE – cup insert 0 ID = 02803448 PE – cup insert 10 ID = 02803152 PE – cup insert 0 ID = 02803444 PE – cup insert 10 ID = 2803148

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)