BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PULSION MEDICAL SYSTEMS SE

    Reg #: 3003263092 · FEI: 3003263092 · Expires 2026
    View on FDA
    Products
    39
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    39

    Registration Details

    Registration Name
    PULSION MEDICAL SYSTEMS SE
    Registration Number
    3003263092
    FEI Number
    3003263092
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Hans-Riedl-Strasse 17
    City
    Feldkirchen Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K172259

    Owner / Operator

    Firm Name
    Maquet Critical Care AB
    Operator Number
    9036213
    Address
    ROENTGENVAGEN 2
    City
    Solna
    State
    SE-NOTA
    Postal Code
    SE-17154
    Country
    SE

    Products

    Device Name Product Code
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Detector And Alarm, Arrhythmia DSI
    Monitor, St Segment MLC
    Adaptor, Lead Switching, Electrocardiograph DRW
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Transducer, Blood-Pressure, Extravascular DRS
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Oximeter DQA
    Recorder, Paper Chart DSF
    Computer, Blood-Pressure DSK
    System, Balloon, Intra-Aortic And Control DSP
    Burst Suppression Detection Software For Electroencephalograph ORT
    Continuous Measurement Thermometer FLL
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Monitor, Carbon-Dioxide, Cutaneous LKD
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Monitor, St Segment With Alarm MLD
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
    Tester, Electrode, Surface, Electrocardiographic KRC
    Electrocardiograph DPS
    Analyzer, Spectrum, Electroencephalogram Signal GWS
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Calculator, Pulmonary Function Data BZC
    System, Network And Communication, Physiological Monitors MSX
    Probe, Thermodilution KRB
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Monitor, Breathing Frequency BZQ
    Alarm, Blood-Pressure DSJ
    System, Signal Isolation DRJ
    Recorder, Magnetic Tape, Medical DSH
    Stimulator, Nerve, Peripheral, Electric KOI

    Proprietary Names

    Inline Injectate temperature Probe PiCCO Module CeVOX Module PulsioFlex Monitor PICCO Temperature Probe ITS Housing PiCCO Catheter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device