BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    ALUS Evolution

    Reg #: 3013300766 · FEI: 3013300766 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    REMEDA AB
    Registration Number
    3013300766
    FEI Number
    3013300766
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Transportvagen 8
    City
    Halmstad Halland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K203061

    Owner / Operator

    Firm Name
    Remeda AB
    Operator Number
    10060619
    Address
    Transportvagen 8
    City
    Halmstad
    State
    Halland
    Postal Code
    30272
    Country
    SE
    Correspondent
    Joel Svensson

    US Agent

    Business Name
    STERIS Corporation
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 3927490

    Products

    Device Name Product Code
    Sterilizer Automated Loading System PEC

    Proprietary Names

    ALUS Evolution

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)