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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
Somfit Pro System
Compumedics Limited
·
,
Australia
Class IIa
FDA 510(k)
K231546
Active
Cleared 30 Nov 2023
CE/MDD
SOMNOscreen plus PSG+ Tele (BT) R&K
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Nox T3s System, EU
Nox Medical
·
,
Iceland
Class IIa
CE/MDR
Reusable Jumper Linker Cable
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class I
CE/MDR
GUDID
on market
SOMNOscreen plus RC (AASM)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
SOMNOtouch™ RESP eco anniversary edition
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
XactTrace Lock - Abdomen
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
XactTrace Belt 65.6ft/20m
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
SOMNOscreen plus PSG+ pediatric (AASM)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Polypro Polysomnograph
Bmc Medical., Ltd.
·
,
China
Class IIa
CE/MDR
XactTrace Extension Cable Thorax 78in/200cm
Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
SOMNO HD PSG Tele wS
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Brainnet 5
Medical Data Technology
·
,
Belgium
Class IIa
CE/MDR
SOMNO HD PSG with PTZ Camera wS
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
Add-on devices: SOMNOtouch RESP (RIP) with thermal airflow recording (pediatric)
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Sleep Adagio PSG small Headbox & PLM
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
Dream
Medical Data Technology
·
,
Belgium
Class IIa
CE/MDR
SOMNO HD EEG32 with PTZ Camera
SOMNOmedics AG
·
,
Germany
Class IIa
CE/MDR
T3s Recorder EU
Nox Medical
·
,
Iceland
Class IIa
CE/MDD
PolyWatch Sleep Screener
Bmc Medical., Ltd.
·
,
China
Class IIa
CE/MDR
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