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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
Polysomnography instruments
Z121005
874 devices
Subcategories
5
Z12100501
Polysomnographs
187
devices
Z12100580
Polysomnography instruments - hardware accessories
268
devices
Z12100582
Polysomnography instruments - software accessories
6
devices
Z12100585
Polysomnography instruments - consumables
402
devices
Z12100592
Polysomnography instruments - medical device software
11
devices
Devices
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
MediByte
Braebon Medical Corporation
·
,
Canada
Class IIa
CE/MDR
28620214964
Active
Valid to Nov 2029
CE/MDD
Somno Hd Rc
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Sphinx HB710 Head Box
Neurotronics, LLC
·
,
United States
Class IIa
CE/MDD
GUDID
on market
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