Public EUDAMED Search

EUDAMED Device Search

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

TR EN

Last updated

22.09.2026 01:15

Sync status

Successful

Device

3420034

Actor

47673

Certificate

3311

Filters

Show filters

Active filter:EMDN:Z12100592

12 device results listed.

Page 1 / 1

CSV XML

08436035524082

Software BitmedLab

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: SIBEL SAU
Manufacturer SRN: ES-MF-000000287
UDI-DI: 08436035524082
Basic UDI-DI: 843603552APOS00102X2
Reference: 09900
EMDN: Z12100592
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 06.08.2026 08:27

Manufacturer products View details

NeuroSpeed-PSG

NeuroSpeed-PSG V 4.23

Class IIaMDDOn the marketActive device

Manufacturer: Compumedics - alpha trace GmbH
Manufacturer SRN: AT-MF-000004575
UDI-DI: 09120119800023
Basic UDI-DI: B-09120119800023
Reference: SW-SRECV
EMDN: Z12100592
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: -
Last updated: 05.08.2026 15:15

Manufacturer products View details

00817111021257

12.2

Class IIaMDDOn the marketActive device

Manufacturer: Neurotronics, LLC
Manufacturer SRN: US-MF-000030839
UDI-DI: 00817111021257
Basic UDI-DI: B-00817111021257
Reference: PS12.2
EMDN: Z12100592
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
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

00817111021172

12.0

Class IIaMDDOn the marketActive device

Manufacturer: Neurotronics, LLC
Manufacturer SRN: US-MF-000030839
UDI-DI: 00817111021172
Basic UDI-DI: B-00817111021172
Reference: PS12.0
EMDN: Z12100592
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
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

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

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

Manufacturer products Authorised representative products Authorised representative actors View details

PC Direct Software

PC Direct

Class IIbMDDNo longer on the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959054318
Basic UDI-DI: B-00606959054318
Reference: 1022090
EMDN: Z12100592
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:10

Manufacturer products Authorised representative products Authorised representative actors View details

Oxevision Sleep System

Sleep

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Oxehealth Limited
Manufacturer SRN: GB-MF-000010055
UDI-DI: 50607514500023
Basic UDI-DI: 506075145SLEEP9J
Reference: Sleep
EMDN: Z12100592
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Sweden
Authorised representative: Oxehealth AB
Last updated: 02.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details

Sleep Profiler

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Advanced Brain Monitoring, Inc.
Manufacturer SRN: US-MF-000011252
UDI-DI: 00851113007017
Basic UDI-DI: 0851113007SP42Q6
Reference: Sleep Profiler Desktop Software
EMDN: Z12100592
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: MPS Medical Product Service GmbH
Last updated: 21.06.2026 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

Sleep Profiler

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Advanced Brain Monitoring, Inc.
Manufacturer SRN: US-MF-000011252
UDI-DI: 00851113007024
Basic UDI-DI: 0851113007SP42Q6
Reference: Sleep Profiler Portal Software
EMDN: Z12100592
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: MPS Medical Product Service GmbH
Last updated: 21.06.2026 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

Stowood Visi-Download

Class IIaNot specifiedOn the market

Manufacturer: Stowood Scientific Instruments Ltd.
Manufacturer SRN: GB-MF-000035931
UDI-DI: 05060504340144
Basic UDI-DI: B-05060504340144
Reference: VDL
EMDN: Z12100592
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: Medaptivo EU Ltd.
Last updated: 19.06.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details