BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Nykanen Radiofrequency Wire

    Reg #: 3020968442 · FEI: 3020968442 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BAYLIS MEDICAL TECHNOLOGIES INC.
    Registration Number
    3020968442
    FEI Number
    3020968442
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2645 Matheson Blvd E
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K990284

    Owner / Operator

    Firm Name
    Baylis Medical Technologies Inc.
    Operator Number
    10082721
    Address
    2645 Matheson Blvd E
    City
    Mississauga
    State
    Ontario
    Postal Code
    L4W5S4
    Country
    CA
    Correspondent
    Meghal Khakhar

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Catheter, Septostomy DXF

    Proprietary Names

    Nykanen Radiofrequency Wire

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198