Eu Mdd Eu Md Class 2b On The Market 🇷🇺 Russian Federation

PATIENT MONITOR MITAR 01 RD

Devices (same UDI-DI)
1
Certificates
1
Countries
31
Notified Bodies
1

Basic Information

Primary DI
04640003830394
Basic UDI-DI Code
B-04640003830394
Reference
-
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

The monitor is intended to be used to control vital physiological parameters: - Heart rate (HR); - Pulse rate (PR); - Respiration rate (RR); - Non-Invasive Blood Pressure (NIBP); - Temperature (T); - Pulse oximetry (SpO2); - Carbon dioxide concentration in exhaled and inspired air (CO2) - Oxygen concentration in exhaled and inspired air (O2) - Nitrous oxide concentration in exhaled and inspired air (N2O) (5 Anesthetic Agents-HAL, ISO, ENF, SEV, DES) - Biseptrical Index (BIS) / Electroensephalography (EEG) The monitor can display the following physiological waveforms: - Electrocardiogram (ECG); - Photoplethysmogram (PPG); - Capnogram (FiCO2, EtCO2); - Oxygram (FiO2, EtO2) - Pneumogram (PG); - Nitrous oxide (FiN2O, EtN2O) - Two anesthetic agents for choice; - Electroensephalogram (EEG) – 2 leads Depending on the monitor model the number of controlled parameters and waveforms may be fewer.

CND Nomenclature Codes

Code Description
Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS

Certificates

Type Number
MDD Annex II (excluding section 4) CE 543428

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye

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