BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Ambu aScope Duodeno

    Reg #: 3016497307 · FEI: 3016497307 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AMBU INNOVATION GMBH
    Registration Number
    3016497307
    FEI Number
    3016497307
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Karl-Drais-Str. 4B
    City
    Augsburg Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K201098

    Owner / Operator

    Firm Name
    Ambu Innovation GmbH
    Operator Number
    10076603
    Address
    Karl-Drais-Str. 4B
    City
    Augsburg
    State
    Bavaria
    Postal Code
    86159
    Country
    DE
    Correspondent
    Simon Cuhlmann

    US Agent

    Business Name
    Ambu Inc
    Contact Name
    Sanjay Parikh
    Address
    6721 Columbia Gateway Drive, Suite 200
    City
    Columbia
    State
    MD
    ZIP
    21046
    Country
    US
    Email
    [email protected]
    Phone
    410 7686464 ext. 1136

    Products

    Device Name Product Code
    Duodenoscope And Accessories, Flexible/Rigid FDT
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET

    Proprietary Names

    Ambu aScope Duodeno Ambu aBox Duodeno

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility