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Software, Sleepware G3, Web

1115720

Class IIaMDDOn the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959045279
Basic UDI-DI: B-00606959045279
Reference: 1115720
EMDN: Z12100582
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

Sleepware G3 Software Package_ML

1082463

Class IIaMDDOn the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959045262
Basic UDI-DI: B-00606959045262
Reference: 1082463
EMDN: Z12100582
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

Apios Software

NS500

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Nomics
Manufacturer SRN: BE-MF-000004514
UDI-DI: 05430002876009
Basic UDI-DI: 543000287664939050007M4
Reference: NS500
EMDN: Z12100592
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: -
Last updated: 16.07.2026 09:59

Manufacturer products View details

PC-Software OR5

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Dr. Fenyves und Gut Deutschland GmbH
Manufacturer SRN: DE-MF-000005715
UDI-DI: 04251978600549
Basic UDI-DI: 42519786040062U
Reference: 925306
EMDN: Z12100582
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:14

Manufacturer products View details

Sonata Patient Recorder

Polysomnographgerät

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Dr. Fenyves und Gut Deutschland GmbH
Manufacturer SRN: DE-MF-000005715
UDI-DI: 04251978600006
Basic UDI-DI: 42519786020052C
Reference: 930010
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:11

Manufacturer products View details

PoSAS

Positional Sleep Assessment System (PoSAS) Software

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Advanced Brain Monitoring, Inc.
Manufacturer SRN: US-MF-000011252
UDI-DI: 00851113007758
Basic UDI-DI: 0851113007PS34PZ
Reference: PS34-5401
EMDN: Z12100592
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: MPS Medical Product Service GmbH
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Sleep Profiler

Sleep Profiler Software

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Advanced Brain Monitoring, Inc.
Manufacturer SRN: US-MF-000011252
UDI-DI: 00850015266706
Basic UDI-DI: 0851113007SP42Q6
Reference: SP42-5402
EMDN: Z12100592
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: MPS Medical Product Service GmbH
Last updated: 16.07.2026 06:28

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Snugglefit Effort Belt

Snuggle Fit Effort Belts

Class IMDR 2017/745On the marketSingle use

Manufacturer: Dymedix Diagnostics, Inc.
Manufacturer SRN: US-MF-000015691
UDI-DI: 00817377022500
Basic UDI-DI: 0817377021813300AG
Reference: 11-14002-1001
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Portugal
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 04:27

Manufacturer products Authorised representative products Authorised representative actors View details

TriplePlay

XM Extremity Movement Sensor

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Dymedix Diagnostics, Inc.
Manufacturer SRN: US-MF-000015691
UDI-DI: 00817377021909
Basic UDI-DI: 08173770213500008P
Reference: 12-10173-0001
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Portugal
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 04:27

Manufacturer products Authorised representative products Authorised representative actors View details

EMG Surface Electrodes

MotionWave EMG Surface Electrodes

Class IMDR 2017/745On the marketSingle use

Manufacturer: Dymedix Diagnostics, Inc.
Manufacturer SRN: US-MF-000015691
UDI-DI: 00817377021367
Basic UDI-DI: 08173770213400008C
Reference: 13-14000-1002
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Portugal
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 04:27

Manufacturer products Authorised representative products Authorised representative actors View details

FastTrack Effort Belt

FastTrack

Class IMDR 2017/745On the marketSingle use

Manufacturer: Dymedix Diagnostics, Inc.
Manufacturer SRN: US-MF-000015691
UDI-DI: 00817377020957
Basic UDI-DI: 08173770211440008E
Reference: 12-10150-0001
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Portugal
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 04:27

Manufacturer products Authorised representative products Authorised representative actors View details

Perfect Fit 3D Effort Belt

Perfect Fit 3D

Class IMDR 2017/745On the marketSingle use

Manufacturer: Dymedix Diagnostics, Inc.
Manufacturer SRN: US-MF-000015691
UDI-DI: 00817377020131
Basic UDI-DI: 08173770211450008M
Reference: 11-14001-5001
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Portugal
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 04:27

Manufacturer products Authorised representative products Authorised representative actors View details

PerfectFit

Perfect Fit II

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: Dymedix Diagnostics, Inc.
Manufacturer SRN: US-MF-000015691
UDI-DI: 00817377020124
Basic UDI-DI: 08173770211100006H
Reference: 11-22100-0301
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Portugal
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 04:27

Manufacturer products Authorised representative products Authorised representative actors View details

AccuSnore

Class IMDR 2017/745On the marketSingle use

Manufacturer: Dymedix Diagnostics, Inc.
Manufacturer SRN: US-MF-000015691
UDI-DI: 00817377020100
Basic UDI-DI: 08173770213100007B
Reference: 10-21001-0301
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Spain
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 04:27

Manufacturer products Authorised representative products Authorised representative actors View details

TriplePlay Airflow

TriplePlay Airflow Sensors

Class IMDR 2017/745On the marketSingle use

Manufacturer: Dymedix Diagnostics, Inc.
Manufacturer SRN: US-MF-000015691
UDI-DI: 00817377020001
Basic UDI-DI: 081737702101000064
Reference: 10-10000-0001
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Spain
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 04:27

Manufacturer products Authorised representative products Authorised representative actors View details

00817111021004

TH01

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Neurotronics, LLC
Manufacturer SRN: US-MF-000030839
UDI-DI: 00817111021004
Basic UDI-DI: 081711102THERM2W
Reference: S29604
EMDN: Z12100580
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 16.07.2026 04:26

Manufacturer products Authorised representative products Authorised representative actors View details

00817111020960

PZ01

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Neurotronics, LLC
Manufacturer SRN: US-MF-000030839
UDI-DI: 00817111020960
Basic UDI-DI: 081711102PIEZO2M
Reference: S60780
EMDN: Z12100580
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 16.07.2026 04:26

Manufacturer products Authorised representative products Authorised representative actors View details

00817111020854

RIP01

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Neurotronics, LLC
Manufacturer SRN: US-MF-000030839
UDI-DI: 00817111020854
Basic UDI-DI: 081711102RIPBC
Reference: S43359
EMDN: Z12100580
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 16.07.2026 04:26

Manufacturer products Authorised representative products Authorised representative actors View details

00817111020823

BP01

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Neurotronics, LLC
Manufacturer SRN: US-MF-000030839
UDI-DI: 00817111020823
Basic UDI-DI: 081711102BODY2V
Reference: S17926
EMDN: Z12100580
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 16.07.2026 04:26

Manufacturer products Authorised representative products Authorised representative actors View details

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Salter Sleep Diagnostic Cannulas

Class IMDR 2017/745On the marketSingle use

Manufacturer: Salter Labs
Manufacturer SRN: US-MF-000007934
UDI-DI: 00607411000980
Basic UDI-DI: 0607411TF20010_SleepDx9V
Reference: 1001-0-25
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 00:52

Manufacturer products Authorised representative products Authorised representative actors View details