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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
SOMNO HD eco RC pediatric
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNOtouch RESP (RIP)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Add-on device: SOMNOtouch RESP (RIP)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Somfit System
Compumedics Limited
·
,
Australia
Class IIa
CE/MDR
CE/MDD
+1
authorizations
XactTrace belt - Small
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
Add-on device: SOMNOtouch™ PSG ambulatory (R&K)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNO HD RC pediatric
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Polypro Portable Sleep Diagnostic System
Bmc Medical., Ltd.
·
,
China
Class IIa
CE/MDR
SOMNOtouch PSG Online (R&K)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
PolyWatch Portable Sleep Diagnostic System
Bmc Medical., Ltd.
·
,
China
Class IIa
CE/MDR
Reusable Touchproof Interconnection Cable
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class I
CE/MDR
GUDID
on market
Sleep Adagio® PSG pro
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Falcon HST
Compumedics Limited
·
,
Australia
Class IIa
FDA 510(k)
K242447
Active
Cleared 20 Feb 2025
CE/MDD
+1
authorizations
SOMNO HD eco PSG Tele
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNO HD eco PSG
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
XactTrace Lock Abdomen EBG
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
Add-on device: SOMNOtouch RESP (RIP, pediatric)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Sleep Adagio® PG pro
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Somfit Charging Cradle
Compumedics Limited
·
,
Australia
Class IIa
CE/MDR
GUDID
on market
SOMNO HD PSG wS
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
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