BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    IS3

    Reg #: 3013206323 · FEI: 3013206323 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    INTEGRATION DIAGNOSTICS SWEDEN AB
    Registration Number
    3013206323
    FEI Number
    3013206323
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Furstenbergsgatan 4
    City
    Goteborg Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K180527

    Owner / Operator

    Firm Name
    Integration Diagnostics Sweden AB
    Operator Number
    10054105
    Address
    Furstenbergsgatan 4
    City
    Goteborg
    State
    Vastra Gotaland
    Postal Code
    41664
    Country
    SE
    Correspondent
    Annika Hallberg

    US Agent

    Business Name
    NSK America Corporation
    Contact Name
    Sean Kaufman
    Address
    1800 Global Parkway
    City
    Hoffman Estates
    State
    IL
    ZIP
    60192
    Country
    US
    Email
    [email protected]
    Phone
    888 6751675

    Products

    Device Name Product Code
    Handpiece, Direct Drive, Ac-Powered EKX

    Proprietary Names

    IS3

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device