BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Sectra Workstation

    Reg #: 9615992 · FEI: 3001104292 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SECTRA AB
    Registration Number
    9615992
    FEI Number
    3001104292
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    TEKNIKRINGEN 20
    City
    LINKOPING Ostergotland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K081469

    Owner / Operator

    Firm Name
    SECTRA AB
    Operator Number
    9026103
    Address
    TEKNIKRINGEN 20, --
    City
    LINKOPING
    State
    SE-NOTA
    Postal Code
    58330
    Country
    SE
    Correspondent
    Edoardo - Mastrovito

    US Agent

    Business Name
    Sectra Inc.
    Contact Name
    Edoardo Mastrovito
    Address
    2 Enterprise Dr Suite 507
    City
    Shelton
    State
    CT
    ZIP
    06484
    Country
    US
    Email
    [email protected]
    Phone
    203 9250899

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Sectra Workstation Sectra Workstation IDS5 Sectra Workstation IDS7 Sectra Workstation UniView

    Establishment Types

    Manufacture Medical Device