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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 sensor with body position
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNOtouch RESP (PLM)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNOscreen™ plus
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
Single Use Universal RIP Kit – Complete
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
XactTrace Extension Cable Abdomen 78in/200cm
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
SOMNOtouch RESP (RIP) with thermal airflow recording
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Grael
Compumedics Limited
·
,
Australia
Class IIa
CE/MDD
GUDID
on market
Somté PSG
Compumedics Limited
·
,
Australia
Class IIa
FDA 510(k)
K021176
Active
Cleared 21 Jan 2003
CE/MDD
+1
authorizations
Reusable Stackable Jumper Linker Cable
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class I
CE/MDR
GUDID
on market
XactTrace Lock - Thorax
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
SOMNOtouch™ RESP
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNOtouch PSG online (EEG)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Add-on device: SOMNOtouch RESP (PLM)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Nox A1S SAS kit
Nox Medical
·
,
Iceland
Class IIa
CE/MDR
SOMNOtouch RESP (RIP, pediatric)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Somno Hd
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNOscreen plus RC easy (pediatric)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNO HD PSG eco with PTZ Camera pediatric
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNO HD eco
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNOtouch PSG online (AASM) pediatric
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
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