Eu Mdd Eu Md Class 2b On The Market

Tempus Pro Patient Monitor

Devices (same UDI-DI)
1
Certificates
1
Countries
18
Notified Bodies
1

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Basic Information

Primary DI
05060472442901
Basic UDI-DI Code
B-05060472442901
Reference
867420
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

Tempus Pro Vital Signs Monitoring System is intended to monitor vital signs on a patient (adult,paediatric and neontate) by a healthcare professional in a pre-clincial setting. The vital signs monitored are:3, 4 and 5-lead ECG monitoring; 12-lead ECG recording with interpretation; realtime arrhythmia detection/alarming; QT measurement/alarming and ST measurements/alarming; impedance pneumography; non-invasive blood pressure (NIBP); end-tidalCO2 (ETCO2) and respiration rate; pulse oximetry (SpO2); contact temperature; and invasive pressure (IP) and extended pulse oximetry capability including; carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb) and total oxygen content (SpOC) measurements.

CND Nomenclature Codes

Code Description
Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS

Certificates

Type Number
MDD Annex II (excluding section 4) 41371410

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇸 Spain 🇫🇷 France 🇭🇷 Croatia 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇺 Luxembourg 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇸🇪 Sweden

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