BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Intuition

    Reg #: 9616014 · FEI: 3002675731 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ARCOMA AB
    Registration Number
    9616014
    FEI Number
    3002675731
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ANNAVAGEN 1
    City
    VAXJO Kronoberg
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K073632

    Owner / Operator

    Firm Name
    ARCOMA AB
    Operator Number
    9035990
    Address
    ANNAVAGEN 1, --
    City
    VAXJO
    State
    SE-NOTA
    Postal Code
    SE-325 46
    Country
    SE
    Correspondent
    Henrik Blomdahl

    US Agent

    Business Name
    Tara Systems Inc.
    Contact Name
    Gary Becker
    Address
    19240 Inkwood Ct.
    City
    Boca Raton
    State
    FL
    ZIP
    33498
    Country
    US
    Email
    [email protected]
    Phone
    561 2126985

    Products

    Device Name Product Code
    System, X-Ray, Stationary KPR

    Proprietary Names

    Intuition

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device