BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    RayTreat 4B

    Reg #: 3007774465 · FEI: 3007774465 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    RaySearch Laboratories AB (publ)
    Registration Number
    3007774465
    FEI Number
    3007774465
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    EUGENIAVAEGEN 18C
    City
    Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K210645

    Owner / Operator

    Firm Name
    RaySearch Laboratories AB (publ)
    Operator Number
    10029973
    Address
    Eugeniavaegen 18C
    City
    Stockholm
    State
    SE-AB
    Postal Code
    11368
    Country
    SE

    US Agent

    Business Name
    RaySearch Americas Inc.
    Contact Name
    Marc Mlyn
    Address
    The Empire State Building, 350 5th Avenue, Suite 5000
    City
    New York
    State
    NY
    ZIP
    10118
    Country
    US
    Email
    [email protected]
    Phone
    877 7783849

    Products

    Device Name Product Code
    System, Planning, Radiation Therapy Treatment MUJ

    Proprietary Names

    RayTreat 4B RayStation 10B RayPlan 10B

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device