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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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Active filter:Manufacturer SRN:US-MF-000017529

187 device results listed.

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MAC 3

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278921628
Basic UDI-DI: 08406821BUG0050573
Reference: 3048726-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Germany
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

MLCL Client Software AltiX AI.i

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278931504
Basic UDI-DI: 8406821BUG00301GV
Reference: 5973597
EMDN: Z12050703
EMDN description: POLYGRAPHY SYSTEMS FOR ELECTROPHYSIOLOGICAL STUDIES
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Mac-Lab AltiX AI.i

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278935632
Basic UDI-DI: 8406821BUG00280HE
Reference: 2400000-003
EMDN: Z12050702
EMDN description: POLYGRAPHY SYSTEMS FOR HAEMODYNAMIC STUDIES
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

CardioLab AltiX AI.i

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278935656
Basic UDI-DI: 8406821BUG00281HG
Reference: 2400000-004
EMDN: Z12050703
EMDN description: POLYGRAPHY SYSTEMS FOR ELECTROPHYSIOLOGICAL STUDIES
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

CareIntellect MUSE

Class IIaMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00198953041741
Basic UDI-DI: 08406821BUG005807H
Reference: 5970545-001
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

B105M Patient Monitor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278490223
Basic UDI-DI: 8406821BUG00323H7
Reference: 6160000-103
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 14.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details

B125P Patient Monitor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278490230
Basic UDI-DI: 8406821BUG00323H7
Reference: 6160000-102
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 14.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details

B125M Patient Monitor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278490247
Basic UDI-DI: 8406821BUG00323H7
Reference: 6160000-104
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 14.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details

B155M Patient Monitor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278490254
Basic UDI-DI: 8406821BUG00323H7
Reference: 6160000-105
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 14.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details

Portrait CAU01

Portrait Clinical Alarming Unit

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682139250
Basic UDI-DI: 8406821BUG00241H4
Reference: 2102549-001
EMDN: Z1203020299
EMDN description: MULTI–PARAMETER MONITORS - OTHER
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

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