BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    7L Platform

    Reg #: 3029904429 · FEI: 3029904429 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    SMARTCARDIA SA
    Registration Number
    3029904429
    FEI Number
    3029904429
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    EPFL Innovation Park
    City
    Lausanne Vaud
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K240653

    Owner / Operator

    Firm Name
    SmartCardia SA
    Operator Number
    10088984
    Address
    EPFL Innovation Park
    City
    Lausanne
    State
    Vaud
    Postal Code
    1015
    Country
    CH
    Correspondent
    Srinivasan Murali

    US Agent

    Business Name
    Steurer Consulting Group
    Contact Name
    Robert Steurer
    Address
    800 Blue Quail Rd
    City
    KELLER
    State
    TX
    ZIP
    76248
    Country
    US
    Email
    [email protected]
    Phone
    425 3581072

    Products

    Device Name Product Code
    Detector And Alarm, Arrhythmia DSI
    Outpatient Cardiac Telemetry QYX
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG

    Proprietary Names

    7L Platform

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198