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

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00195278421388

Vivid iq

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00195278421388
Basic UDI-DI: 8406821BUG00254HD
Reference: Vivid iq v206/5877072
EMDN: Z11040102
EMDN description: CARDIOLOGY ULTRASOUND SCANNERS
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

Novii+ Pod

Novii+ Wireless Patch System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00195278115171
Basic UDI-DI: 8406821BUG00458HX
Reference: 5514130
EMDN: Z1208010403
EMDN description: TRANSMITTING UNITS FOR CARDIOTOCOGRAPHIC TELEMETRY
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

Giraffe Blue Spot PT Lite

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00195278022233
Basic UDI-DI: 8406821BUG00394HW
Reference: M1238506
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: Türkiye
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

AMX Navigate

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278003348
Basic UDI-DI: 8406821BUG00267HN
Reference: 5844925
EMDN: Z11039016
EMDN description: MOBILE RADIOGRAPHIC UNITS
First on market country: Finland
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

ML4-20-D

ML4-20 probes family

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Parallel Design, Inc.
Manufacturer SRN: US-MF-000009295
UDI-DI: 00195278002723
Basic UDI-DI: 8406821BUG00337HJ
Reference: 5838850
EMDN: Z110402010101
EMDN description: TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES
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

Novii Patch

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 15060433670074
Basic UDI-DI: 8406821BUG00146H9
Reference: 107-PT-004
EMDN: Z1208010485
EMDN description: CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:48

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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

NOVII INTERFACE CABLE - GE FECG

NOVII INTERFACE CABLE

Class IMDR 2017/745On the market

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 05060433670091
Basic UDI-DI: 8406821BUG00136H6
Reference: 105-PT-102
EMDN: -
EMDN description: CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - 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

NM/CT 870 CZT

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Israel, Functional Imaging
Manufacturer SRN: IL-MF-000003062
UDI-DI: 00840682159463
Basic UDI-DI: 8406821BUG00007GS
Reference: H3906EX , H3906EW
EMDN: Z11020201
EMDN description: CT/GAMMA CAMERA SYSTEMS
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

Centricity Cardio Workflow v7.0

Centricity Cardio Workflow

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Healthcare
Manufacturer SRN: US-MF-000001862
UDI-DI: 00840682147200
Basic UDI-DI: 8406821BUG00002GG
Reference: 5838392
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
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

Centricity RIS-i 7.0.x

Centricity RIS-i

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Healthcare
Manufacturer SRN: US-MF-000001862
UDI-DI: 00840682147170
Basic UDI-DI: 8406821BUG00009GW
Reference: 5841488
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
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

Pressure Diffusing Mattress

2076066-001

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682146869
Basic UDI-DI: 8406821BUG00158HG
Reference: 2076066-001
EMDN: V028099
EMDN description: NEONATOLOGY AND PEDIATRICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: Austria
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

SIGNA Prime

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00840682146302
Basic UDI-DI: 8406821BUG00029H4
Reference: SIGNA Prime
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
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

1.5T AIR MP L

Class IMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Coils
Manufacturer SRN: US-MF-000001664
UDI-DI: 00840682145626
Basic UDI-DI: 8406821BUG00134H2
Reference: 5020701
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
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

1.5T AIR MP M

Class IMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Coils
Manufacturer SRN: US-MF-000001664
UDI-DI: 00840682145619
Basic UDI-DI: 8406821BUG00147HB
Reference: 5020601
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
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

3.0T AIR MP M

Class IMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Coils
Manufacturer SRN: US-MF-000001664
UDI-DI: 00840682145602
Basic UDI-DI: 8406821BUG00132GW
Reference: 5040801
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
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