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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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Neurology and neurosurgery instruments
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Polysomnography instruments
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Polysomnographs
Polysomnographs
Z12100501
187 devices
SOMNOtouch NIBP incl. ECG/IC-EMG Sensor
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Somfit System
Compumedics Limited
·
,
Australia
Class IIa
CE/MDD
MediByte Jr
Braebon Medical Corporation
·
,
Canada
Class IIa
CE/MDD
CE/MDR
28620214964
Active
Valid to Nov 2029
SOMNOscreen plus PSG+ BT (R&K)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Sleepscan
Somno Engineering
·
,
France
Class IIa
CE/MDR
Sleep Adagio PSG PRO
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNOtouch PSG ambulatory (AASM)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Add-on device: SOMNOtouch PSG ambulatory (AASM)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNOtouch PSG ambulatory (EEG)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Single Use Universal RIP Kit - Thorax
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
XactTrace Snap Sensor Cable, Thorax- 78in/200cm
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
XactTrace Snap Sensor Cable - Abdomen
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
Grael
Compumedics Limited
·
,
Australia
Class IIa
FDA 510(k)
K093223
Active
Cleared 15 Jan 2010
CE/MDD
Reusable Shielded 3-in-1 Monopolar Extension Cable
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class I
CE/MDR
GUDID
on market
Stowood Black Shadow
Stowood Scientific Instruments Ltd.
·
,
United Kingdom
Class IIa
CE/MDD
SOMNOtouch NIBP incl. ECG/IC-EMG Sensor and Flow Sensor
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNOtouch RESP (pediatric)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Stowood Black Flash
Stowood Scientific Instruments Ltd.
·
,
United Kingdom
Class IIa
CE/MDD
SOMNOtouch PSG online (EEG) and PTZ Camera
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNOscreen plus PSG+ R&K
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
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