BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    RAUMEDIC-ICP-Monitoring-System

    Reg #: 3006942548 · FEI: 3006942548 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RAUMEDIC - Werk Zwoenitz
    Registration Number
    3006942548
    FEI Number
    3006942548
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Am Muehlgraben 10
    City
    Zwoenitz Saxony
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K103206

    Owner / Operator

    Firm Name
    RAUMEDIC
    Operator Number
    10024509
    Address
    Hermann-Staudinger-Str. 2
    City
    Helmbrechts
    State
    Bavaria
    Postal Code
    95233
    Country
    DE
    Correspondent
    Hannes Engelhardt

    US Agent

    Business Name
    RAUMEDIC Inc.
    Contact Name
    Jeremy Smith
    Address
    235 Broadpointe Dr
    City
    Mills River
    State
    NC
    ZIP
    28759
    Country
    US
    Email
    [email protected]
    Phone
    828 4903262

    Products

    Device Name Product Code
    Device, Monitoring, Intracranial Pressure GWM

    Proprietary Names

    RAUMEDIC-ICP-Monitoring-System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)