BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    SWISSRAY Medical, AG

    Reg #: 9614430 · FEI: 3002143662 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    SWISSRAY Medical, AG
    Registration Number
    9614430
    FEI Number
    3002143662
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    TURBISTRASSE 25-27
    City
    HOCHDORF Luzern
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K160620

    Owner / Operator

    Firm Name
    Swissray Medical AG
    Operator Number
    9003721
    Address
    1037 MacArthur Blvd, Unit 881
    City
    Mahwah
    State
    NJ
    Postal Code
    07430
    Country
    US
    Correspondent
    Bradley Utts

    US Agent

    Business Name
    Swissray Medical AG
    Contact Name
    Bradley Utts
    Address
    1037 Macarthur Blvd Unit 881
    City
    Mahwah
    State
    NJ
    ZIP
    07430
    Country
    US
    Email
    [email protected]
    Phone
    800 9035543

    Products

    Device Name Product Code
    System, X-Ray, Stationary KPR
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Mobile IZL

    Proprietary Names

    ddrAura (TM) Series ddRFormula Plus ddRFormula ddRCruze ddRCruze Plus ddRElement

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198