BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Coala Heart Monitor

    Reg #: 3014745300 · FEI: 3014745300 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Coala Solutions AB
    Registration Number
    3014745300
    FEI Number
    3014745300
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bangardsgatan 13
    City
    Uppsala
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K182040

    Owner / Operator

    Firm Name
    Coala Solutions Inc
    Operator Number
    10060490
    Address
    1130 Wall St, Unit 611
    City
    La Jolla
    State
    CA
    Postal Code
    92037
    Country
    US
    Correspondent
    Magnus Sorlander

    Products

    Device Name Product Code
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    Coala Heart Monitor

    Establishment Types

    Manufacture Medical Device