BEUDAMED
    FDA Registration Active 🇨🇿 Czechia

    ICU Medical Czech Republic a. s.

    Reg #: 3011237704 · FEI: 3011237704 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    37
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    ICU Medical Czech Republic a. s.
    Registration Number
    3011237704
    FEI Number
    3011237704
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Olomoucka 306
    City
    Hranice Olomoucky Kraj
    Country
    CZ

    Regulatory Submissions

    510(k) Number
    K961404

    Owner / Operator

    Firm Name
    ICU Medical, Inc.
    Operator Number
    8020727
    Address
    951 Calle Amanecer
    City
    San Clemente
    State
    CA
    Postal Code
    92673
    Country
    US
    Correspondent
    Michelle Doherty

    US Agent

    Business Name
    ICU Medical, Inc.
    Contact Name
    Michelle Doherty
    Address
    951 Calle Amanecer
    City
    San Clemente
    State
    CA
    ZIP
    92673
    Country
    US
    Email
    [email protected]
    Phone
    949 3706562

    Products

    Device Name Product Code
    Transducer, Blood-Pressure, Extravascular DRS
    Tube, Tracheostomy (W/Wo Connector) BTO
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Arterial Blood Sampling Kit CBT
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Anesthesia Conduction Kit CAZ
    Filter, Conduction, Anesthetic BSN
    Needle, Spinal, Short Term MIA
    Tube Tracheostomy And Tube Cuff JOH
    Needle, Emergency Airway BWC
    Gauge, Measuring JYJ

    Proprietary Names

    LogiCal(R) Portex BLUselect Tracheostomy Tube Portex BLUselect Suctionaid Tracheostomy Tube Portex BLUselect Tracheostomy Inner Cannula Portex UniPerc Adjustable Flange Tracheostomy Tube UniPerc PDT Kit UniPerc Percutaneous Dilation Tracheostomy Kit Portex Blue Line Ultra Tracheostomy Kit Suctionaid Portex Blue Line Ultra Suctionaid Trachostomy Tube Kits BL Ultra Suctionaid Change Kits Blue Line Ultra Suctionaid Blue Line Ultra Tracheostomy Tubes and Kits Portex Blue Line Ultra Tracheostomy Kit Portex Blue Line Ultra Tracheostomy Tube Portex Blue Line Ultra Tracheostomy Tube Inner Cannula Blue Line Ultra Inner Cannulas Pneupac paraPAC plus Disposable CPAP Circuit Pneupac paraPAC plus HemoDraw Portex Filter Straw with NRFit Connector Portex Epidural Flat Filter with NRFit Connector Portex L.O.R. Syringes with NRFit Connector Portex EpiFuse Catheter with NRFit Connector Portex Filter Needle with NRFit Connector Portex combined Spinal/Epidural Minipack Portex Epidural Minipack System Pencil Point Spinal Needle Portex Regional Anesthesia Catheter Connector Single Shot Epidural tray/kit Continuous Epidural tray/kit Spinal tray/kit BLUperc Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or without BLUselect Tracheostomy Tube BLUgriggs Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect Tracheostomy Tube with or without Portex Emergency Cricothyroidotomy Portex Emergency Cricothyroidotomy Kit PORTEX CUFF PRESSURE GAUGE

    Establishment Types

    Manufacture Medical Device