BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Uni FB PE-insert ID = 40101014

    Reg #: 3002808022 · FEI: 3002808022 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    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
    K203341

    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, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX

    Proprietary Names

    Uni FB PE-insert ID = 40101014 Uni FB PE-insert ID = 40100308 Uni FB PE-insert ID = 40101009 Uni FB PE-insert ID = 40100110 Uni FB PE-insert ID = 40100208 Uni FB PE-insert ID = 40100212 Uni FB PE-insert ID = 40100310 Uni FB PE-insert ID = 40100210 Uni FB PE-insert ID = 40100111 Uni FB PE-insert ID = 40100411 Uni FB PE-insert ID = 40101011 Uni FB PE-insert ID = 40100114 Uni FB PE-insert ID = 40100408 Uni FB PE-insert ID = 40101012 Uni FB PE-insert ID = 40100311 Uni FB PE-insert ID = 40100309 Uni FB PE-insert ID = 40100109 Uni FB PE-insert ID = 40100214 Uni FB PE-insert ID = 40100414 Uni FB PE-insert ID = 40101010 Uni FB PE-insert ID = 40100112 Uni FB PE-insert ID = 40100211 Uni FB PE-insert ID = 40100312 Uni FB PE-insert = 40100412 Uni FB PE-insert ID = 40100410 Uni FB PE-insert ID = 40100209 Uni FB PE-insert ID = 40100314 Uni FB PE-insert ID = 40100409 Uni FB PE-insert ID = 40100108 Uni FB PE-insert ID = 40101008

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)