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443 device results listed.

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FastTrack Effort Belt

Class INot specifiedOn the marketSingle use

Manufacturer: Dymedix Diagnostics, Inc.
Manufacturer SRN: US-MF-000015691
UDI-DI: 00817377023040
Basic UDI-DI: 08173770211440008E
Reference: 18-14260-0602
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.07.2026 17:52

Manufacturer products Authorised representative products Authorised representative actors View details

FastTrack Effort Belt

Class INot specifiedOn the marketSingle use

Manufacturer: Dymedix Diagnostics, Inc.
Manufacturer SRN: US-MF-000015691
UDI-DI: 00817377023057
Basic UDI-DI: 08173770211440008E
Reference: 11-44400-0001
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.07.2026 17:52

Manufacturer products Authorised representative products Authorised representative actors View details

EEG Electrodes

Class INot specifiedOn the marketSingle use

Manufacturer: Dymedix Diagnostics, Inc.
Manufacturer SRN: US-MF-000015691
UDI-DI: 00817377023064
Basic UDI-DI: 08173770213101007G
Reference: 13-10200-1010
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.07.2026 17:52

Manufacturer products Authorised representative products Authorised representative actors View details

EEG Electrodes

Class INot specifiedOn the marketSingle use

Manufacturer: Dymedix Diagnostics, Inc.
Manufacturer SRN: US-MF-000015691
UDI-DI: 00817377023071
Basic UDI-DI: 08173770213101007G
Reference: 13-10200-8010
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.07.2026 17:52

Manufacturer products Authorised representative products Authorised representative actors View details

EEG Electrodes

Class INot specifiedOn the marketSingle use

Manufacturer: Dymedix Diagnostics, Inc.
Manufacturer SRN: US-MF-000015691
UDI-DI: 00817377023088
Basic UDI-DI: 08173770213101007G
Reference: 13-10200-4010
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.07.2026 17:52

Manufacturer products Authorised representative products Authorised representative actors View details

EEG Electrodes

Class INot specifiedOn the marketSingle use

Manufacturer: Dymedix Diagnostics, Inc.
Manufacturer SRN: US-MF-000015691
UDI-DI: 00817377023095
Basic UDI-DI: 08173770213101007G
Reference: 13-10200-6010
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.07.2026 17:52

Manufacturer products Authorised representative products Authorised representative actors View details

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

Filter

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

Ultima Pressure Sensor Hydrophobic Filter

0583

Class IMDR 2017/745On the marketSingle use

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14005830
Basic UDI-DI: ++B140FilterJ2
Reference: 0583
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

Ultima Nasal Cannula + Filter

Airflow Cannula

Class IMDR 2017/745No longer on the marketSingle use

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14005820
Basic UDI-DI: ++B140CannulaPD
Reference: 0582
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

MediByte to CPAP Adapter

8552

Class IMDR 2017/745On the market

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14085520
Basic UDI-DI: ++B140TubingQ4
Reference: 8552
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

Ultima PVDF Respiratory Effort Sensor

Respiratory Effort Sensors

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14005200
Basic UDI-DI: ++B140EffortFU
Reference: 0520
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

Paper Tape

0305

Class IMDR 2017/745On the marketSingle use

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14003050
Basic UDI-DI: ++B140TapeHH
Reference: 0305
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details