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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

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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

Magnifico MSK

100009

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Esaote S.p.A.
Manufacturer SRN: IT-MF-000019024
UDI-DI: 08056304454744
Basic UDI-DI: 805630445ESA.MR0000001.PU
Reference: 100009910
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

Magnifico Open

100009

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Esaote S.p.A.
Manufacturer SRN: IT-MF-000019024
UDI-DI: 08056304454737
Basic UDI-DI: 805630445ESA.MR0000002.PX
Reference: 100009900
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

TMJ COIL 19

MRI system, accessory Risk Class I

Class IMDR 2017/745On the marketActive device

Manufacturer: Esaote S.p.A.
Manufacturer SRN: IT-MF-000019024
UDI-DI: 08056304452344
Basic UDI-DI: 805630445ESA.MR0000006.QB
Reference: 130000005
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:13

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APF 001 - Asta porta flebo amagnetica MR Safe

APF 001

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Enclara Medical s.r.l.
Manufacturer SRN: IT-MF-000013110
UDI-DI: 08053307710266
Basic UDI-DI: 8053307711119U
Reference: APF 001
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:41

Manufacturer products View details

CRM 001 2R - Carrello risonanza magnetica 2 ripiani

CRM 001

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Enclara Medical s.r.l.
Manufacturer SRN: IT-MF-000013110
UDI-DI: 08053307710204
Basic UDI-DI: 8053307711109S
Reference: CRM 001 2R
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:41

Manufacturer products View details

Sedia amagnetica MR safe

SRM 001

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Enclara Medical s.r.l.
Manufacturer SRN: IT-MF-000013110
UDI-DI: 08053307710150
Basic UDI-DI: 805330771107A5
Reference: SRM 001
EMDN: Z11059099
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:41

Manufacturer products View details

Predellino amagnetico 2 Gradini

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Enclara Medical s.r.l.
Manufacturer SRN: IT-MF-000013110
UDI-DI: 08053307710143
Basic UDI-DI: 805330771106A3
Reference: SA2G
EMDN: Z11059099
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:41

Manufacturer products View details

Barella amagnetica leggera

BRM 002

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Enclara Medical s.r.l.
Manufacturer SRN: IT-MF-000013110
UDI-DI: 08053307710136
Basic UDI-DI: 8053307711059Z
Reference: BRM 002
EMDN: Z11059099
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:41

Manufacturer products View details

MR Safe Patient Trolley

BRM 001

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Enclara Medical s.r.l.
Manufacturer SRN: IT-MF-000013110
UDI-DI: 08053307710068
Basic UDI-DI: 8053307711019R
Reference: BRM 001
EMDN: Z11059099
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:41

Manufacturer products View details

07350140460411

AMRA Profiler 4

Class IIbMDR 2017/745On the marketActive device

Manufacturer: AMRA Medical AB
Manufacturer SRN: SE-MF-000008820
UDI-DI: 07350140460411
Basic UDI-DI: 7350140460417Q
Reference: 041
EMDN: Z11059082
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:05

Manufacturer products View details

cNeuro cMRI

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: SyntheticMR AB
Manufacturer SRN: SE-MF-000003513
UDI-DI: 07340024710008
Basic UDI-DI: 73400247S02QR
Reference: 0
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: -
Last updated: 03.07.2026 04:19

Manufacturer products View details

SyMRI 12

SyMRI

Class IIaMDR 2017/745On the marketActive device

Manufacturer: SyntheticMR AB
Manufacturer SRN: SE-MF-000003513
UDI-DI: 07340024700047
Basic UDI-DI: 73400247S01QP
Reference: 0004
EMDN: Z11050182
EMDN description: MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

Manufacturer products View details

IMROC -IR

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Optoacoustics Ltd.
Manufacturer SRN: IL-MF-000011000
UDI-DI: 07290019141006
Basic UDI-DI: 7290019141006WR
Reference: 0000
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

06975312910030

Magnetic Resonance Imaging System

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Kuanteng (Liaoning) Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000010538
UDI-DI: 06975312910030
Basic UDI-DI: 697531292000JL
Reference: 2000
EMDN: Z11050102
EMDN description: OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T
First on market country: Malta
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

06974197600685

uAI Clinical Portal MRI

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shanghai United Imaging Intelligence Co., Ltd.
Manufacturer SRN: CN-MF-000035682
UDI-DI: 06974197600685
Basic UDI-DI: 697419760CPortalMRIVV
Reference: AI303007
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details