BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    RaySearch Laboratories AB (publ)

    Reg #: 3007774465 · FEI: 3007774465 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    20
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    RaySearch Laboratories AB (publ)
    Registration Number
    3007774465
    FEI Number
    3007774465
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    EUGENIAVAEGEN 18C
    City
    Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K220141

    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

    RayPlan 11B RayStation 11B RayCare 3.1 RayTreat 5A RayStation 11A RayPlan 11A RayStation RayStation 12A RayStation 2023B RayPlan 12A RayPlan 2023B RayCare 2024A SP1 RayPlan 10A RayStation 10A RayStation 9B RayPlan 9B RayPlan 10B RayTreat 4B RayStation 10B RayStation 8B

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device