BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SonoTip Pro and Pro Flex EBUS-TBNA Needle System

    Reg #: 9680809 · FEI: 3002995060 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    MEDI-GLOBE GMBH
    Registration Number
    9680809
    FEI Number
    3002995060
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Medi-Globe Strasse 1-5
    City
    Achenmuhle, Germany Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K133763

    Owner / Operator

    Firm Name
    MEDI-GLOBE GMBH
    Operator Number
    9011628
    Address
    MEDI-GLOBE-STRASSE, 1-5, --
    City
    ACHENMUHLE
    State
    Bavaria
    Postal Code
    D-83101
    Country
    DE
    Correspondent
    Stephan - Schneider

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Biopsy Needle FCG

    Proprietary Names

    SonoTip Pro and Pro Flex EBUS-TBNA Needle System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device