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223 device results listed.

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Alice 5 International Base Unit Only

1017230

Class IIaMDDNo longer on the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020368
Basic UDI-DI: B-00606959020368
Reference: 1017230
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alice LE System INTL

Alice 5 and Alice LE Polysomnography Systems

Class IIaMDDNo longer on the marketMeasuring function

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020245
Basic UDI-DI: B-00606959020245
Reference: 1002288
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

09342451002747

Falcon HST System EU

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Compumedics Limited
Manufacturer SRN: AU-MF-000050437
UDI-DI: 09342451002747
Basic UDI-DI: 9342451FalconH9
Reference: 8036-0002-02
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: Compumedics EUROPE GmbH
Last updated: 04.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

09342451002655

Somfit

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Compumedics Limited
Manufacturer SRN: AU-MF-000050437
UDI-DI: 09342451002655
Basic UDI-DI: 9342451SomfitTU
Reference: 8037-0001-00
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: Compumedics EUROPE GmbH
Last updated: 04.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

09342451001382

Somte PSG v2

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Compumedics Limited
Manufacturer SRN: AU-MF-000050437
UDI-DI: 09342451001382
Basic UDI-DI: 9342451SomtePSGTN
Reference: 8023-0001-02
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: Compumedics EUROPE GmbH
Last updated: 04.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

SleepDoc Porti 10 PSG 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: 04251978600914
Basic UDI-DI: 42519786020052C
Reference: 930011
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:14

Manufacturer products View details

SOMNOtouch™ RESP

SOMNOtouch

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: SOMNOmedics AG
Manufacturer SRN: DE-MF-000006921
UDI-DI: 04250413404384
Basic UDI-DI: 42504134PSGSC
Reference: TOR050
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 21:31

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Sleep Adagio® PG

Sleep Adagio

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: SOMNOmedics AG
Manufacturer SRN: DE-MF-000006921
UDI-DI: 04250413403837
Basic UDI-DI: 42504134SleepA36
Reference: SAZ050
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 21:31

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SOMNO HD PSG eco with PTZ Camera

SOMNO HD

Class IIaMDR 2017/745On the market

Manufacturer: SOMNOmedics AG
Manufacturer SRN: DE-PR-000042026
UDI-DI: 04250413402779
Basic UDI-DI: 42504134SOMNOHDND
Reference: NGNV202A
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 21:31

Manufacturer products View details

Add-on device: SOMNOtouch RESP (pediatric)

SOMNOtouch RESP

Class IIaMDR 2017/745On the market

Manufacturer: SOMNOmedics AG
Manufacturer SRN: DE-PR-000042026
UDI-DI: 04250413402168
Basic UDI-DI: 42504134SOMNOtouchRESPZS
Reference: TOR105A
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 21:31

Manufacturer products View details

SOMNOscreen™ plus

SOMNOscreen

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: SOMNOmedics AG
Manufacturer SRN: DE-MF-000006921
UDI-DI: 04250413400195
Basic UDI-DI: 42504134SSCPKB
Reference: SSP704
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 21:30

Manufacturer products View details

SOMNOscreen plus RC easy

SOMNOscreen plus

Class IIaMDR 2017/745On the market

Manufacturer: SOMNOmedics AG
Manufacturer SRN: DE-PR-000042026
UDI-DI: 04250413400010
Basic UDI-DI: 42504134SOMNOscreenplusEQ
Reference: SSP500
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 21:30

Manufacturer products View details

SLEEPSCAN

Class IIaMDR 2017/745On the marketDirect markingMeasuring function

Manufacturer: SOMNO ENGINEERING
Manufacturer SRN: FR-MF-000043221
UDI-DI: 03770035921027
Basic UDI-DI: 3770035921SLEEPSCANMG
Reference: 327-1847DF777
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:14

Manufacturer products View details

Nox A1S SAS kit

NOX-A1S_SAS

Class IIaMDR 2017/745On the market

Manufacturer: Nox Medical
Manufacturer SRN: IS-PR-000054327
UDI-DI: 15694311112082
Basic UDI-DI: 1569431111NOX_A1SSASKITYY
Reference: 513013
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 12:09

Manufacturer products View details

A1s System

NOX-A1S_EUF

Class IIaMDR 2017/745On the market

Manufacturer: Nox Medical
Manufacturer SRN: IS-PR-000054327
UDI-DI: 15694311111573
Basic UDI-DI: 1569431111NOX_A1KITQA
Reference: 513012
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 12:09

Manufacturer products View details

Nox T3s System, EU

NOX-T3S_EUF

Class IIaMDR 2017/745On the market

Manufacturer: Nox Medical
Manufacturer SRN: IS-PR-000054327
UDI-DI: 15694311111450
Basic UDI-DI: 1569431111NOX_T3KITX9
Reference: 511012
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 12:08

Manufacturer products View details

Polypro Polysomnograph

Sleep Apnea Diagnosis Device

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: BMC Medical Co., Ltd.
Manufacturer SRN: CN-MF-000010157
UDI-DI: 06948538361139
Basic UDI-DI: 69485383SD001T3
Reference: H2 Pro
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 04:16

Manufacturer products Authorised representative products Authorised representative actors View details

Polypro Polysomnograph

Sleep Apnea Diagnosis Device

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: BMC Medical Co., Ltd.
Manufacturer SRN: CN-MF-000010157
UDI-DI: 06948538361122
Basic UDI-DI: 69485383SD001T3
Reference: H2 Elite
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 04:16

Manufacturer products Authorised representative products Authorised representative actors View details

Polypro Portable Sleep Diagnostic System

Sleep Apnea Diagnosis Device

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: BMC Medical Co., Ltd.
Manufacturer SRN: CN-MF-000010157
UDI-DI: 06948538361115
Basic UDI-DI: 69485383SD001T3
Reference: H2 Plus
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 04:16

Manufacturer products Authorised representative products Authorised representative actors View details

Polypro Portable Sleep Diagnostic System

Sleep Apnea Diagnosis Device

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: BMC Medical Co., Ltd.
Manufacturer SRN: CN-MF-000010157
UDI-DI: 06948538361108
Basic UDI-DI: 69485383SD001T3
Reference: H2
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details