BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    MY01 Continuous Compartmental Pressure Monitor

    Reg #: 3017398927 · FEI: 3017398927 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MY01, INC.
    Registration Number
    3017398927
    FEI Number
    3017398927
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    400 De Maisonneuve Boulevard West, Suite 700
    City
    Montreal Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K210525

    Owner / Operator

    Firm Name
    MY01, Inc.
    Operator Number
    10061277
    Address
    400 De Maisonneuve Boulevard West, Suite 700
    City
    Montreal
    State
    Quebec
    Postal Code
    H3A 1L4
    Country
    CA

    US Agent

    Business Name
    mdi Consultants, Inc.
    Contact Name
    Alan Schwartz
    Address
    55 Northern Blvd Ste 200
    City
    Great Neck
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Monitor, Pressure, Intracompartmental LXC

    Proprietary Names

    MY01 Continuous Compartmental Pressure Monitor

    Establishment Types

    Manufacture Medical Device