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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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MAC 7 Resting ECG Analysis System

MAC 7

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278620873
Basic UDI-DI: 8406821BUG00386HX
Reference: 2119091-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

Portrait VSM

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278561312
Basic UDI-DI: 8406821BUG00384HT
Reference: 6660000-666
EMDN: Z1203020202
EMDN description: TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

CARESCAPE PDM (Patient Data Module)

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278510747
Basic UDI-DI: 8406821BUG00298HZ
Reference: 5863573
EMDN: Z1203020202
EMDN description: TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

MLCL Client Software AltiX

MLCL Client Software

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278507525
Basic UDI-DI: 8406821BUG00301GV
Reference: 5889605
EMDN: Z12050703
EMDN description: POLYGRAPHY SYSTEMS FOR ELECTROPHYSIOLOGICAL STUDIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

VSP 4.0 Upgrade Software

VSP 4.0

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278490742
Basic UDI-DI: 8406821BUG00329HK
Reference: 5877259
EMDN: Z1203020282
EMDN description: MULTI-PARAMETER MONITORS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

B105P Patient Monitor

B105P

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278488473
Basic UDI-DI: 8406821BUG00323H7
Reference: 6160000-101
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

CASE V7.0

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278617644
Basic UDI-DI: 8406821BUG00170H6
Reference: 3031234-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:18

Manufacturer products Authorised representative products Authorised representative actors View details

ComboLab AltiX

ComboLab

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278507051
Basic UDI-DI: 8406821BUG00282HJ
Reference: 2300000-005
EMDN: Z12050703
EMDN description: POLYGRAPHY SYSTEMS FOR ELECTROPHYSIOLOGICAL STUDIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

CardioLab AltiX

CardioLab

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278507044
Basic UDI-DI: 8406821BUG00281HG
Reference: 2300000-004
EMDN: Z12050703
EMDN description: POLYGRAPHY SYSTEMS FOR ELECTROPHYSIOLOGICAL STUDIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

Mac-Lab AltiX

Mac-Lab

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278507037
Basic UDI-DI: 8406821BUG00280HE
Reference: 2300000-003
EMDN: Z12050702
EMDN description: POLYGRAPHY SYSTEMS FOR HAEMODYNAMIC STUDIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

Portrait CVAXB

Portrait Central Viewer Application

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278656681
Basic UDI-DI: 8406821BUG00425HG
Reference: 5863721-11
EMDN: Z12030201
EMDN description: CENTRAL INFORMATION COMPUTING SYSTEMS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Portrait Core Services CSSXB

Portrait Core Services

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278659446
Basic UDI-DI: 8406821BUG00424HE
Reference: 5933539
EMDN: Z1203020292
EMDN description: MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

MAC 7 SW UPG KIT

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278840202
Basic UDI-DI: 8406821BUG00386HX
Reference: 2227007-021
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
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

CARESCAPE Gateway

5697315-002

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278888235
Basic UDI-DI: 08406821BUG005287F
Reference: 5697315-002
EMDN: Z1203020292
EMDN description: MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

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 IIbNot specifiedOn 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