BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    COMBI 40+ Cochlear Implant System: Maestro Cochlear Implant System

    Reg #: 3002808022 · FEI: 3002808022 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    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

    PMA Number
    P000025

    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
    Implant, Cochlear MCM

    Proprietary Names

    COMBI 40+ Cochlear Implant System: Maestro Cochlear Implant System Mi1200 SYNCHRONY PIN Cochlear Implant Mi1250 SYNCHRONY 2 Cochlear Implant Vibrant Soundbridge (VORP 502) PULSAR CI 100 Mi1250 SYNCHRONY 2 PIN Cochlear Implant SONATA TI N100 Cochlear Implant Mi1200 SYNCHRONY Cochlear Implant S- Vector Magnet Replacement Kit (S- Vector Replacement Magnet & Non- Magnetic Spacer) Insertion Test Device (ITD) Mi1000 MED-EL CONCERT PIN Cochlear Implant Insertion Electrode (IE) Variants Mi1000 MED-EL CONCERT Cochlear Implant Mi1210 SYNCHRONY ST Cochlear Implant Magnet Replacement Kit (Replacement Magnet & Non-Magnetic Spacer) Mi1260 SONATA 2 Cochlear Implant Mi1250 SYNCHRONY 2 PIN Cochlear Implant with S- Vector Magnet Mi1250 SYNCHRONY 2 Cochlear Implant with S- Vector Magnet

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)