BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    The ENDOPATH ECHELON and ECHELON FLEX families of endoscopic linear cutters and reload

    Reg #: 3021194552 · FEI: 3021194552 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDINEEDLE - RESCUE GROUP RETTUNGSDIENST
    Registration Number
    3021194552
    FEI Number
    3021194552
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bruckenstrabe 10
    City
    Wolpertshausen Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K140560

    Owner / Operator

    Firm Name
    Medineedle - Rescue Group Rettungsdienst
    Operator Number
    10057331
    Address
    Bruckenstrabe 10
    City
    Wolpertshausen
    State
    Bavaria
    Postal Code
    74549
    Country
    DE
    Correspondent
    Marco Schelhorn

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Staple, Implantable GDW

    Proprietary Names

    The ENDOPATH ECHELON and ECHELON FLEX families of endoscopic linear cutters and reload

    Establishment Types

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