BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Michele Sleep Scoring System

    Reg #: 3008517706 · FEI: 3008517706 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CEREBRA MEDICAL
    Registration Number
    3008517706
    FEI Number
    3008517706
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1470 Willson Place Unit B
    City
    Winnipeg Manitoba
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K112102

    Owner / Operator

    Firm Name
    Cerebra Medical
    Operator Number
    10033319
    Address
    1470 Willson Place Unit B
    City
    Winnipeg
    State
    Manitoba
    Postal Code
    R3T 3N9
    Country
    CA

    US Agent

    Business Name
    MDSS USA LLC
    Contact Name
    Marissa Vilchez
    Address
    6118 W. Lawrence Avenue
    City
    Chicago
    State
    IL
    ZIP
    60630
    Country
    US
    Email
    [email protected]
    Phone
    312 9751694

    Products

    Device Name Product Code
    Ventilatory Effort Recorder MNR

    Proprietary Names

    Michele Sleep Scoring System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device