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EUDAMED Device Search

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

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183 device results listed.

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MUSE NX

Class IIaMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278458070
Basic UDI-DI: 8406821BUG00305H5
Reference: 4101010-002
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EK12

Starting from V2

Class IIaMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278457547
Basic UDI-DI: 8406821BUG00415HD
Reference: 2104498-003
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

KISS+

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278441874
Basic UDI-DI: 8406821BUG00292HM
Reference: 2093551-100
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

Portrait CCS01

Portrait Core Services

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278341129
Basic UDI-DI: 8406821BUG00239HH
Reference: 5870857
EMDN: Z1203020292
EMDN description: MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

Portrait CVA01

Portrait Central Viewer Application

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278330413
Basic UDI-DI: 8406821BUG00240H2
Reference: 5863721
EMDN: Z12030201
EMDN description: CENTRAL INFORMATION COMPUTING SYSTEMS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

MAC 5 A4 Resting ECG Analysis System

MAC 5 A4

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278276070
Basic UDI-DI: 8406821BUG00244HA
Reference: 8855001-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Germany
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

B1X5-REC Recorder

B1X5-REC

Class IMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682180689
Basic UDI-DI: 8406821BUG00055H5
Reference: 2097478-002
EMDN: Z1203020280
EMDN description: MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:47

Manufacturer products Authorised representative products Authorised representative actors View details

B105M Patient Monitor

B105P B125P B105M B125M B155M

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682146708
Basic UDI-DI: 8406821BUG00102GM
Reference: 6160000-003
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:47

Manufacturer products Authorised representative products Authorised representative actors View details

MAC 7

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682144322
Basic UDI-DI: 8406821BUG00013GM
Reference: 2109091-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:47

Manufacturer products Authorised representative products Authorised representative actors View details

B1X5-F2 Second Frame

Class IMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682140935
Basic UDI-DI: 8406821BUG00054H3
Reference: 2104800-001
EMDN: Z1203020280
EMDN description: MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

MAC 600

Class IIaMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682134859
Basic UDI-DI: 8406821BUG00169HM
Reference: 2042216-003
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

Y-ADAPTOR 1 TB BARB MALE 3/32 TO 2 TB NEO-SNAP MALE, SINGLE

NIBP Adaptor and Connectors

Class IMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682134927
Basic UDI-DI: 8406821BUG00040GQ
Reference: 2054883-221
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

ECG LEADWIRE SET

CS ONE ECG Cable and Leadwires

Class IMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682125710
Basic UDI-DI: 8406821BUG00121GR
Reference: 2066468-005
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

CARESCAPE ECG

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682124607
Basic UDI-DI: 8406821BUG00171H8
Reference: 2099884-001
EMDN: Z1203020280
EMDN description: MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

CARESCAPE Pressure

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682123969
Basic UDI-DI: 8406821BUG00172HA
Reference: 2099660-001
EMDN: Z1203020280
EMDN description: MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

CARESCAPE Temperature

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682123952
Basic UDI-DI: 8406821BUG00173HC
Reference: 2099661-001
EMDN: Z1203020280
EMDN description: MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

CARESCAPE SpO2

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682123921
Basic UDI-DI: 8406821BUG00174HE
Reference: 2099662-001
EMDN: Z1203020280
EMDN description: MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

DS1 SYNC TO UNTERM-15FT

Defib Sync Cables

Class IMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682117425
Basic UDI-DI: 8406821BUG00026GW
Reference: 2017842-001
EMDN: Z1203020280
EMDN description: MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

ASSY CARE HOSE ADULT/PED 2T DINACLICK 3.6M 80369-5

NIBP Hoses

Class IMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682116626
Basic UDI-DI: 8406821BUG00039H7
Reference: 2058203-002
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

DURA-CUF, LARGE ADULT LONG, 1 TB BAYONET, 31 - 40 CM, SINGLE

DURA-CUF Non-Invasive Blood Pressure Cuff

Class IMDR 2017/745On the marketDirect markingMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682110549
Basic UDI-DI: 8406821BUG00036GZ
Reference: 2054880-113
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:45

Manufacturer products Authorised representative products Authorised representative actors View details