BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    CARDIOCOMM SOLUTIONS, INC.

    Reg #: 9680510 · FEI: 3003708031 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    25
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    CARDIOCOMM SOLUTIONS, INC.
    Registration Number
    9680510
    FEI Number
    3003708031
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    110 Sheppard Avenue East Suite 700, Suite 700
    City
    North York Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K121009

    Owner / Operator

    Firm Name
    CardioComm Solutions, Inc.
    Operator Number
    9009563
    Address
    18 Wynford Drive, Suite 305
    City
    Toronto
    State
    Ontario
    Postal Code
    M3C2S2
    Country
    CA

    US Agent

    Business Name
    AJW Technology Consultants, Inc.
    Contact Name
    Jon Ward
    Address
    11705 Boyette Road, #503
    City
    Riverview
    State
    FL
    ZIP
    33569
    Country
    US
    Email
    [email protected]
    Phone
    813 6452855 ext. 104

    Products

    Device Name Product Code
    Electrocardiograph DPS
    Recorder, Magnetic Tape, Medical DSH
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    HeartCheck ECG Pen GEMS Home GEMS Auto Attendant GEMS Air GEMS Flex GEMS HL7 GEMS Win GEMS WIN Global ECG Management System (GEMS) GEMS Lite GC12 SMART Monitoring GC3 GlobalCardio GlobalCardio Flex GEMS Flex SMART Monitoring HeartCheck CardiBeat GEMS Mobile HeartCheck Pen GC12 Flex GlobalCardio 12 Flex GlobalCardio 12 Guava Flex Guava II HeartCheck Handheld ECG Monitor

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Foreign Private Label Distributor