BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    MEDICALGORITHMICS S.A.

    Reg #: 3007770164 · FEI: 3007770164 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    MEDICALGORITHMICS S.A.
    Registration Number
    3007770164
    FEI Number
    3007770164
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    AL. JEROZOLIMSKIE 81
    City
    WARSAW Mazowieckie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K253141

    Owner / Operator

    Firm Name
    Medicalgorithmics S.A.
    Operator Number
    10029709
    Address
    Al. Jerozolimskie 81, VAT ID:521-336-14-57
    City
    WARSAW
    State
    Mazowieckie
    Postal Code
    02-001
    Country
    PL
    Correspondent
    Michal Zapora

    US Agent

    Business Name
    Medicalgorithmics US Holding Corporation
    Contact Name
    Joanna Dabala
    Address
    Corporation Service Company, 251 Little Falls Dr
    City
    Wilmington
    State
    DE
    ZIP
    19808
    Country
    US
    Email
    [email protected]
    Phone
    302 2615184

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK
    Outpatient Cardiac Telemetry QYX
    Electrocardiograph DPS
    Detector And Alarm, Arrhythmia DSI
    Electrocardiograph, Ambulatory (Without Analysis) MWJ

    Proprietary Names

    DeepRhythmAI Unified Arrhythmia Diagnostic System PocketECG IV Q Patch DeepRhythm Platform DRP

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device