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Neuro Insight V1.0

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Olea Medical S.A.S.
Manufacturer SRN: FR-MF-000002403
UDI-DI: +EOLENEUROINSIGHTV1P00
Basic UDI-DI: ++EOLENEUROINSIGHTPM
Reference: AP-NI-MR; AP-NI-NP-MR; AP-NI-NS-MR
EMDN: Z11050182
EMDN description: MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 19:09

Manufacturer products View details

MR Diffusion Perfusion Mismatch V1.0

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Olea Medical S.A.S.
Manufacturer SRN: FR-MF-000002403
UDI-DI: +EOLEMRDPMV1P00
Basic UDI-DI: ++EOLEMRDPM96
Reference: AP-NV-DP-MR
EMDN: Z11050182
EMDN description: MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 19:09

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MR DWI/FLAIR Measurement V1.0

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Olea Medical S.A.S.
Manufacturer SRN: FR-MF-000002403
UDI-DI: +EOLEMRDFMV1P00
Basic UDI-DI: ++EOLEMRDFM88
Reference: AP-NV-DF-MR
EMDN: Z11050182
EMDN description: MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 19:09

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Functional MR V1.0

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Olea Medical S.A.S.
Manufacturer SRN: FR-MF-000002403
UDI-DI: +EOLEFUNCTIONALMRV1P00
Basic UDI-DI: ++EOLEFUNCTIONALMRDS
Reference: MOD030
EMDN: Z11050182
EMDN description: MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 19:09

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CT Perfusion V1.0

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Olea Medical S.A.S.
Manufacturer SRN: FR-MF-000002403
UDI-DI: +EOLECTPERFUSIONV1P00
Basic UDI-DI: ++EOLECTPERFUSIONDG
Reference: AP-NV-CTP
EMDN: Z11050182
EMDN description: MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 19:09

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breastscape V1.0

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Olea Medical S.A.S.
Manufacturer SRN: FR-MF-000002403
UDI-DI: +EOLEBREASTCAPEV1P00
Basic UDI-DI: ++EOLEBREASTSCAPEYM
Reference: SCPT001;SCPT002
EMDN: Z11050182
EMDN description: MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 19:09

Manufacturer products View details

AI DWI Mismatch V1.0

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Olea Medical S.A.S.
Manufacturer SRN: FR-MF-000002403
UDI-DI: +EOLEAIDMV1P00
Basic UDI-DI: ++EOLEAIDM72
Reference: AP-NV-AIDM-MR
EMDN: Z11050182
EMDN description: MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 19:09

Manufacturer products View details

+B5450340000010

MRopen EVO

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: ASG Superconductors S.p.A.
Manufacturer SRN: IT-MF-000029567
UDI-DI: +B5450340000010
Basic UDI-DI: ++B545034000ZK
Reference: 03-4000-00 V1
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: 15.07.2026 14:49

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MROpen Evo

03-2000-00

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: ASG Superconductors S.p.A.
Manufacturer SRN: IT-MF-000029567
UDI-DI: +B54503200000120
Basic UDI-DI: ++B545032000Z5
Reference: 03-2000-00 V12
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: 15.07.2026 14:49

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Neuroreader

Class IMDDOn the marketActive device

Manufacturer: Brainreader A/S
Manufacturer SRN: DK-MF-000030456
UDI-DI: D-NR-LEGACY-001UN
Basic UDI-DI: B-NR-LEGACY-001UN
Reference: NR-LEGACY-001
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: -
Last updated: 14.07.2026 05:24

Manufacturer products View details

MRI Pad

Class IMDDOn the market

Manufacturer: Multiwave Imaging
Manufacturer SRN: FR-MF-000007919
UDI-DI: D-FR-MF-0000079194Y
Basic UDI-DI: B-FR-MF-0000079194Y
Reference: 7 TNS
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 21:39

Manufacturer products View details

Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®)

BPX 30

Class IIaMDDOn the marketContains latexSingle use

Manufacturer: DxTx Medical, Inc.
Manufacturer SRN: US-MF-000026795
UDI-DI: 10850011472177
Basic UDI-DI: B-10850011472177
Reference: BPX 30
EMDN: Z1105018002
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY VOLUMETRIC COILS
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 11.07.2026 04:36

Manufacturer products Authorised representative products Authorised representative actors View details

Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®)

BPX 15

Class IIaMDDOn the marketContains latexSingle use

Manufacturer: DxTx Medical, Inc.
Manufacturer SRN: US-MF-000026795
UDI-DI: 10850011472146
Basic UDI-DI: B-10850011472146
Reference: BPX 15
EMDN: Z1105018002
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY VOLUMETRIC COILS
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 11.07.2026 04:36

Manufacturer products Authorised representative products Authorised representative actors View details

MAGNETOM Altea

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthineers AG
Manufacturer SRN: DE-MF-000038456
UDI-DI: 04068151995114
Basic UDI-DI: 0405686902279W2
Reference: 11344915
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: -
Authorised representative: -
Last updated: 10.07.2026 22:58

Manufacturer products View details

MAGNETOM Altea

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869230726
Basic UDI-DI: 0405686900125UQ
Reference: 11410371
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: -
Authorised representative: -
Last updated: 10.07.2026 22:58

Manufacturer products View details

MAGNETOM Altea

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthineers AG
Manufacturer SRN: DE-MF-000038456
UDI-DI: 04068151995121
Basic UDI-DI: 0405686902279W2
Reference: 11410371
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: -
Authorised representative: -
Last updated: 10.07.2026 22:58

Manufacturer products View details

MAGNETOM Avanto Fit

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869299266
Basic UDI-DI: 0405686900125UQ
Reference: 11516216
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: -
Authorised representative: -
Last updated: 10.07.2026 22:57

Manufacturer products View details

MAGNETOM Cima.X

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869975221
Basic UDI-DI: 0405686900125UQ
Reference: 11647158
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: -
Authorised representative: -
Last updated: 10.07.2026 22:56

Manufacturer products View details

MAGNETOM Cima.X

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869996509
Basic UDI-DI: 0405686900125UQ
Reference: 11689616
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: -
Authorised representative: -
Last updated: 10.07.2026 22:56

Manufacturer products View details

MAGNETOM Cima.X

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869975245
Basic UDI-DI: 0405686900125UQ
Reference: 11689304
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: -
Authorised representative: -
Last updated: 10.07.2026 22:56

Manufacturer products View details