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3” Round Coil 1.5T

Class IMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00840682116008
Basic UDI-DI: 8406821BUG00143H3
Reference: 2127315
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 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

1.5T GEM PVA

1.5T GEM Coil Suite

Class IMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Coils
Manufacturer SRN: US-MF-000001664
UDI-DI: 00840682115780
Basic UDI-DI: 8406821BUG00176HJ
Reference: 5372731
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 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

3.0T LAA

3.0T HNU / UAA / LAA

Class IMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Coils
Manufacturer SRN: US-MF-000001664
UDI-DI: 00840682107082
Basic UDI-DI: 8406821BUG00195HN
Reference: 5452049
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 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

MR High Impedance ECG Cable

Class IMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00840682102452
Basic UDI-DI: 8406821BUG00153H6
Reference: 5122500 (E8819HZ)
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
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

1.5T HDxt Upgrade Kit

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278416339
Basic UDI-DI: 8406821BUG00105GT
Reference: 1.5T HDxt Upgrade Kit
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 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

MR VesselIQ Xpress

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278301253
Basic UDI-DI: 8406821BUG00076HD
Reference: 5854372
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 03.07.2026 12:42

Manufacturer products View details

READY View

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278301161
Basic UDI-DI: 8406821BUG00080H4
Reference: 5854368
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 03.07.2026 12:41

Manufacturer products View details

PROView

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278301147
Basic UDI-DI: 8406821BUG00079HK
Reference: 5854366
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 03.07.2026 12:41

Manufacturer products View details

GenIQ

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278301055
Basic UDI-DI: 8406821BUG00072H5
Reference: 5854358
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 03.07.2026 12:41

Manufacturer products View details

FlightPlan for EVAR

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278301017
Basic UDI-DI: 8406821BUG00070GZ
Reference: 5854356
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 03.07.2026 12:41

Manufacturer products View details

DV GOC Upgrade Console

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278229519
Basic UDI-DI: 8406821BUG00150GY
Reference: DV GOC Upgrade Console
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 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Voyager

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278124609
Basic UDI-DI: 8406821BUG00101GK
Reference: SIGNA Voyager
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 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Artist

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278117021
Basic UDI-DI: 8406821BUG00098HP
Reference: SIGNA Artist
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 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Architect

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278023643
Basic UDI-DI: 8406821BUG00003GJ
Reference: SIGNA Architect
EMDN: Z11050105
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Premier

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278010797
Basic UDI-DI: 8406821BUG00092HB
Reference: SIGNA Premier
EMDN: Z11050105
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Pioneer

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278005502
Basic UDI-DI: 8406821BUG00093HD
Reference: SIGNA Pioneer
EMDN: Z11050105
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

I-Genius

100019

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Esaote S.p.A.
Manufacturer SRN: IT-MF-000019024
UDI-DI: 08056304456120
Basic UDI-DI: 805630445ESA.MR0000007.QE
Reference: 100019400
EMDN: Z11050102
EMDN description: OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:14

Manufacturer products View details

O-scan Smart

100002

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Esaote S.p.A.
Manufacturer SRN: IT-MF-000019024
UDI-DI: 08056304455741
Basic UDI-DI: 805630445ESA.MR0000005.Q8
Reference: 100002100
EMDN: Z11050101
EMDN description: SECTORAL TOMOGRAPHS (FOR TOMOGRAPHIC EXAMINATIONS OF THE EXTREMITIES)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:14

Manufacturer products View details

S-scan MSK

100001

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Esaote S.p.A.
Manufacturer SRN: IT-MF-000019024
UDI-DI: 08056304455277
Basic UDI-DI: 805630445ESA.MR0000003.Q2
Reference: 100001810
EMDN: Z11050101
EMDN description: SECTORAL TOMOGRAPHS (FOR TOMOGRAPHIC EXAMINATIONS OF THE EXTREMITIES)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:14

Manufacturer products View details

S-scan Open

100001

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Esaote S.p.A.
Manufacturer SRN: IT-MF-000019024
UDI-DI: 08056304455055
Basic UDI-DI: 805630445ESA.MR0000004.Q5
Reference: 100001800
EMDN: Z11050102
EMDN description: OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:14

Manufacturer products View details