BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Ocean Chest Drain

    Reg #: 9681630 · FEI: 3002808845 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Rommelag CDMO GmbH
    Registration Number
    9681630
    FEI Number
    3002808845
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Banhofstrasse
    City
    Sulzbach-Laufen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K043582

    Owner / Operator

    Firm Name
    Rommelag CDMO GmbH
    Operator Number
    10028922
    Address
    Bahnhofstrasse
    City
    Sulzbach-Laufen
    State
    Baden-Wurttemberg
    Postal Code
    74429
    Country
    DE
    Correspondent
    Martin Haerer

    US Agent

    Business Name
    Parexel International
    Contact Name
    Brian Dietz
    Address
    2520 Meridian Parkway, Research Triangle Park, Suite 200
    City
    Durham
    State
    NC
    ZIP
    27713
    Country
    US
    Email
    [email protected]
    Phone
    919 5443170

    Products

    Device Name Product Code
    Bottle, Collection, Vacuum KDQ

    Proprietary Names

    Ocean Chest Drain

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)