Manufacturer

Compumedics

AustraliaLegal entities : Compumedics Limited

First countries of placing on the market declared in EUDAMED : Germany

Public contracts won : France 8

EU representative : Compumedics EUROPE GmbH (Germany)

Website support@compumedics.com.au

7 categories, 58 models including 58 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Polysomnography instruments - consumables	Z12100585	18” black snap lead 2 pack3 refs Abdominal Band Lead, Male/Male Plug, 2m (Blue)3 refs Disposable Airflow Sensor Kit Disposable Inductive Belt 40xBelts (20 Sets) Disposable Inductive Belt Lead - 580mm YELLOW3 refs 18 others Disposable Oximeter Sensor Kit ECG Leads 10Pk Multicolored 96"2 refs Falcon CPAP Adaptor Kit3 refs Falcon Disposable Effort Belt Pair3 refs Falcon Disposable Electrode & Cable Kit3 refs Gold Cup Electrodes - 2pk Green 30"3 refs Grael Position Sensor Grael PSG Sensor kit3 refs Grael RIP band and Abdominal cable, blue 205cm3 refs Grael Tracheal Microphone Inductive Respiratory Band (band only) Position Sensor V8 Adult/Paediatric TP3 refs Somfit Electrode2 refs Somfit Pro Dual Band Single Night Consumable pack3 refs Somte PSG v2 Start Up Kit2 refs Somté Left / Right Leg Sensor Starter Kit Disposable Adult Inductive Effort Belts (10 Sets)2 refs Triple Thermistor Airflow Sensor	I, IIa MDR	EUDAMED record Report an error
Electroencephalographs	Z12100302	Grael DC Assembly with Cable93/42 Grael EEG - EU3 refs Grael Extension Box93/42 Grael LT System, no software93/42 Neuvo System Unit3 refs 11 others Okti 128 Ch Ambulatory EEG Recorder Only3 refs Okti 128 Ch Ambulatory EEG System93/42 Okti 128 Ch Wall Mount System93/42 Okti 32 Ch Ambulatory EEG System93/42 Okti 32 Ch Fixed System93/42 Okti 64 Ch Ambulatory EEG System93/42 Okti Ethernet Connection Kit93/42 SynAmps RT System Unit Package + IMECSU-2 SynAmps2/RT3 refs SynAmpsRT 64-Channel Headbox Package93/42 SynAmpsRT Power Unit Package93/42 SynAmpsRT System Unit Package93/42	IIa MDR, 93/42	EUDAMED record Report an error
Polysomnographs	Z12100501	Falcon Docking Cradle Assembly Falcon HST System EU3 refs Falcon HST System93/42 Grael PSG Package -Grael PG, PSG Starter Kit93/42 Grael PSG System, No software93/42 Grael v2 System with PSG 5 Software93/42 5 others Respifit Device - Somfit Pro upgrade kit3 refs Somfit Pro System EU93/42 Somfit System Europe93/42 Somfit System Europe (7 electrodes)93/42 Somte PSG v22 refs	IIa MDR, 93/42	EUDAMED record Report an error
Electroencephalography instruments - consumables	Z12100385	Ag/AgCl Sintered Electrode, 24PK 40 Inch2 refs Disposable microphone Sensor Kit Grael Event Button3 refs Okti Start Up Kit	I MDR	EUDAMED record Report an error
Electroencephalography instruments - medical device software	Z12100392	CURRY 9 Profusion EEG Version 6 Profusion EEG Version 72 refs	IIa MDR	EUDAMED record Report an error
Polysomnography instruments - hardware accessories	Z12100580	Grael DC Somte PSG v2 Ground Adaptor	I MDR	EUDAMED record Report an error
Polysomnography instruments - medical device software	Z12100592	Profusion Sleep Version 5	IIa MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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