BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MEDI-GLOBE GMBH

    Reg #: 3011146996 · FEI: 3011146996 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    MEDI-GLOBE GMBH
    Registration Number
    3011146996
    FEI Number
    3011146996
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LOGISTICS CENTER, SUDRING 21
    City
    VELEN North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K061222

    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
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Biopsy Needle FCG
    Snare, Flexible FDI
    Bottle, Collection, Vacuum KDQ
    Stents, Drains And Dilators For The Biliary Ducts FGE

    Proprietary Names

    ClickTip Injectra SonoTip Pro and Pro Flex EBUS-TBNA Needle System Orbit-Snare RotaSnare SonoTip II Clear View Pro Control Vizeon SonoTip II 25 gauge EUS needle Optimizer Polyp Trap Endoflux™ Biliary & Pancreatic Stent Sets

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device