BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    XION GmbH

    Reg #: 9515015 · FEI: 3003276727 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    5

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    Registration Details

    Registration Name
    XION GmbH
    Registration Number
    9515015
    FEI Number
    3003276727
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Pankstrasse 8
    City
    Berlin
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K941541

    Owner / Operator

    Firm Name
    HENKE-SASS WOLF, GMBH.
    Operator Number
    8010418
    Address
    Keltenstrasse 1, --
    City
    TUTTLINGEN
    State
    Baden-Wurttemberg
    Postal Code
    D-78532
    Country
    DE

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Hysteroscope (And Accessories) HIH
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Otoscope ERA

    Proprietary Names

    XION Laparoscopes HSW Laparosopes & Accessories XION Sinuscppes HSW Nasopharyngoscope & Accessories XION Hysteroscopes XION Otoscope

    Establishment Types

    Repack or Relabel Medical Device