BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    OPSENS INC.

    Reg #: 3008061490 · FEI: 3008061490 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    OPSENS INC.
    Registration Number
    3008061490
    FEI Number
    3008061490
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    750, Boulevard du Parc Technologique
    City
    Quebec City
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K152991

    Owner / Operator

    Firm Name
    Opsens Inc.
    Operator Number
    10049773
    Address
    750, Boulevard du Parc Technologique
    City
    Quebec City
    State
    CA-QC
    Postal Code
    G1P 4S3
    Country
    CA
    Correspondent
    Marc Chaunet

    US Agent

    Business Name
    Haemonetics Corporation
    Contact Name
    Julie Ryan
    Address
    125 Summer St
    City
    Boston
    State
    MA
    ZIP
    02110
    Country
    US
    Email
    [email protected]
    Phone
    781 6900575

    Products

    Device Name Product Code
    Transducer, Pressure, Catheter Tip DXO
    Wire, Guide, Catheter DQX
    Electrode, Pacemaker, Temporary LDF
    Adjunctive Cardiovascular Status Indicator PPW

    Proprietary Names

    OptoWire OptoWire Deux SavvyWire OptoMonitor 3 OptoWire III OptoMonitor 2 PacePro Wire OptoWire and OptoMonitor System OptoWire One OptoMonitor System OptoMonitor

    Establishment Types

    Manufacture Medical Device