BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    ARCOMA AB

    Reg #: 9616014 · FEI: 3002675731 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    ARCOMA AB
    Registration Number
    9616014
    FEI Number
    3002675731
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ANNAVAGEN 1
    City
    VAXJO Kronoberg
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K140683

    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 ext. 0

    Products

    Device Name Product Code
    Holder, Radiographic Cassette, Wall-Mounted IXY
    Table, Radiographic, Non-Tilting, Powered IZZ
    Tube Mount, X-Ray, Diagnostic IYB
    Table, Radiographic, Tilting IXR
    System, X-Ray, Stationary KPR
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    ARCOCOMB ARCO TABLE NT ARCOCEIL 0047-BT Urology table 0047-CV Vascular Imaging Table 0047-T Elite and Precision Imaging Table Omnera 400T Omnera 500A Omnera 400A

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)