BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    CarbonAid, CarbonMini

    Reg #: 3005555621 · FEI: 3005555621 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CARDIA INNOVATION AB
    Registration Number
    3005555621
    FEI Number
    3005555621
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Manskarsvagen 10B
    City
    Kungens Kurva Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K112975

    Owner / Operator

    Firm Name
    CARDIA INNOVATION AB
    Operator Number
    9076128
    Address
    Manskarsvagen 10B, --
    City
    Kungens Kurva
    State
    SE-NOTA
    Postal Code
    SE 141 75
    Country
    SE
    Correspondent
    Marie van der Linden

    US Agent

    Business Name
    M Squared Associates/a PPG Company
    Contact Name
    Cherita James
    Address
    1129 20th St NW, Suite 600
    City
    Washington
    State
    DC
    ZIP
    20036
    Country
    US
    Email
    [email protected]
    Phone
    347 9540624

    Products

    Device Name Product Code
    Insufflator, Laparoscopic HIF

    Proprietary Names

    CarbonAid, CarbonMini

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device