BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    EXPLORER AIR Sterile Drape

    Reg #: 3026934906 · FEI: 3026934906 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SURGVISION GMBH
    Registration Number
    3026934906
    FEI Number
    3026934906
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kistlerhofstr. 70 (building 79)
    City
    Muenchen Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K222240

    Owner / Operator

    Firm Name
    SurgVision GmbH
    Operator Number
    10087568
    Address
    Kistlerhofstr. 70 (building 79)
    City
    Muenchen
    State
    Bavaria
    Postal Code
    81379
    Country
    DE
    Correspondent
    Adrian Taruttis

    US Agent

    Business Name
    ACIST Medical Systems, Inc.
    Contact Name
    Jonathan Watkins
    Address
    7905 Fuller Road
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US
    Email
    [email protected]
    Phone
    651 8558002

    Products

    Device Name Product Code
    Confocal Optical Imaging OWN
    System, X-Ray, Angiographic IZI

    Proprietary Names

    EXPLORER AIR Sterile Drape EXPLORER AIR II

    Establishment Types

    Manufacture Medical Device