BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Paragon Adult Maxi PMP Oxygenator with Tubing Pack

    Reg #: 3013267343 · FEI: 3013267343 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Chalice Medical Ltd
    Registration Number
    3013267343
    FEI Number
    3013267343
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Manton Wood Enterprise Park
    City
    Worksop Nottinghamshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K201642

    Owner / Operator

    Firm Name
    Chalice Medical Limited
    Operator Number
    10059431
    Address
    Units 1-2 Manton Wood Enterprise Park, Drayton Court
    City
    Worksop
    State
    Nottinghamshire
    Postal Code
    S80 2RS
    Country
    GB

    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
    Oxygenator, Cardiopulmonary Bypass DTZ
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Heat-Exchanger, Cardiopulmonary Bypass DTR

    Proprietary Names

    Paragon Adult Maxi PMP Oxygenator with Tubing Pack

    Establishment Types

    Manufacture Medical Device