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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

22.09.2026 01:15

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233 device results listed.

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Respifit Device - Somfit Pro upgrade kit

Somfit Respifit Module – Somfit Pro Upgrade Kit

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Compumedics Limited
Manufacturer SRN: AU-MF-000050437
UDI-DI: 09342451006592
Basic UDI-DI: 9342451SomfitTU
Reference: 9037-0020-00
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: Compumedics EUROPE GmbH
Last updated: 22.09.2026 00:46

Manufacturer products Authorised representative products Authorised representative actors View details

Somfit Respiratory Module Charging Cradle

-

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Compumedics Limited
Manufacturer SRN: AU-MF-000050437
UDI-DI: 09342451006011
Basic UDI-DI: 9342451SomfitTU
Reference: 8037-0102-01
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: Compumedics EUROPE GmbH
Last updated: 22.09.2026 00:46

Manufacturer products Authorised representative products Authorised representative actors View details

Somfit Respiratory Module

-

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Compumedics Limited
Manufacturer SRN: AU-MF-000050437
UDI-DI: 09342451006004
Basic UDI-DI: 9342451SomfitTU
Reference: 8037-0002-01
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: Compumedics EUROPE GmbH
Last updated: 22.09.2026 00:46

Manufacturer products Authorised representative products Authorised representative actors View details

Somfit Pro - EU

-

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Compumedics Limited
Manufacturer SRN: AU-MF-000050437
UDI-DI: 09342451007315
Basic UDI-DI: 9342451SomfitTU
Reference: 9037-0016-02
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: Compumedics EUROPE GmbH
Last updated: 22.09.2026 00:46

Manufacturer products Authorised representative products Authorised representative actors View details

Somfit Charging Cradle

-

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Compumedics Limited
Manufacturer SRN: AU-MF-000050437
UDI-DI: 09342451002662
Basic UDI-DI: 9342451SomfitTU
Reference: 8037-0101-00
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: Compumedics EUROPE GmbH
Last updated: 22.09.2026 00:46

Manufacturer products Authorised representative products Authorised representative actors View details

Somfit Main Unit

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: 22.09.2026 00:46

Manufacturer products Authorised representative products Authorised representative actors View details

-

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Compumedics Limited
Manufacturer SRN: AU-MF-000050437
UDI-DI: 09342451007308
Basic UDI-DI: 9342451SomfitTU
Reference: 9037-0002-02
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: Compumedics EUROPE GmbH
Last updated: 22.09.2026 00:46

Manufacturer products Authorised representative products Authorised representative actors View details

Sistema Screen&Go

Sistema Screen&Go / Sleep&Go

Class IIaMDR 2017/745On the market

Manufacturer: SIBEL SAU
Manufacturer SRN: ES-PR-000052577
UDI-DI: 08436035524211
Basic UDI-DI: 843603552APOY00102ZG
Reference: 09895-S
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 08:27

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Polígrafo Screen&Go

Polígrafo Screen&Go / Sleep&Go

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: SIBEL SAU
Manufacturer SRN: ES-MF-000000287
UDI-DI: 08436035524037
Basic UDI-DI: 843603552APOP00102VT
Reference: 09895
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Spain
Authorised representative: -
Last updated: 06.08.2026 08:27

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Polígrafo Sleep&Go A

-

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: SIBEL SAU
Manufacturer SRN: ES-MF-000000287
UDI-DI: 08436035524044
Basic UDI-DI: 843603552APOP00102VT
Reference: 09896
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 08:18

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Polígrafo Sleep&Go B

-

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: SIBEL SAU
Manufacturer SRN: ES-MF-000000287
UDI-DI: 08436035524051
Basic UDI-DI: 843603552APOP00102VT
Reference: 09897
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 08:18

Manufacturer products View details

Sistema Sleep&Go A

-

Class IIaMDR 2017/745On the market

Manufacturer: SIBEL SAU
Manufacturer SRN: ES-PR-000052577
UDI-DI: 08436035524228
Basic UDI-DI: 843603552APOY00102ZG
Reference: 09896-S
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 08:18

Manufacturer products View details

Sistema Sleep&Go B

-

Class IIaMDR 2017/745On the market

Manufacturer: SIBEL SAU
Manufacturer SRN: ES-PR-000052577
UDI-DI: 08436035524235
Basic UDI-DI: 843603552APOY00102ZG
Reference: 09897-S
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 08:18

Manufacturer products View details

SleepDoc Porti 10 PSG Neuro Module

Neuro Module

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Dr. Fenyves und Gut Deutschland GmbH
Manufacturer SRN: DE-MF-000005715
UDI-DI: 04251978600921
Basic UDI-DI: 42519786030072P
Reference: 930021
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 21:27

Manufacturer products View details

-

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B140MP80
Basic UDI-DI: ++B140MediByte4Q
Reference: MP-8
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 04.08.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

Sonata Neuro Module 10-20

-

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Dr. Fenyves und Gut Deutschland GmbH
Manufacturer SRN: DE-MF-000005715
UDI-DI: 04251978600952
Basic UDI-DI: 42519786030072P
Reference: 930022
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:55

Manufacturer products View details

VitalNight PSG Neuro Module

-

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Dr. Fenyves und Gut Deutschland GmbH
Manufacturer SRN: DE-MF-000005715
UDI-DI: 04251978601287
Basic UDI-DI: 42519786030072P
Reference: 930023
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:55

Manufacturer products View details

Sphinx PMU710

Class IIaMDDOn the marketActive device

Manufacturer: Neurotronics, LLC
Manufacturer SRN: US-MF-000030839
UDI-DI: 00817111020335
Basic UDI-DI: B-00817111020335
Reference: HB710
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 01.08.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

Sphinx PMU710

Class IIaMDDOn the marketActive device

Manufacturer: Neurotronics, LLC
Manufacturer SRN: US-MF-000030839
UDI-DI: 00817111020205
Basic UDI-DI: B-00817111020205
Reference: CU710
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 01.08.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

WatchPAT ONE

Class IIaMDR 2017/745On the marketActive deviceMeasuring functionSingle use

Manufacturer: Itamar Medical Ltd.
Manufacturer SRN: IL-MF-000012046
UDI-DI: 07290109222424
Basic UDI-DI: 729010922AC21508MX
Reference: AC2110800
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Latvia
Authorised representative: Arazy Group GmbH
Last updated: 31.07.2026 21:56

Manufacturer products Authorised representative products Authorised representative actors View details