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MAGNETOM Amira

MDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom

Class IIaMDR 2017/745On the marketNo EU rep

Manufacturer: Siemens Shenzhen Magnetic Resonance Ltd.
Manufacturer SRN: CN-PR-000020467
UDI-DI: 04056869265841
Basic UDI-DI: 0405686900131UK
Reference: 11568941
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: 16.07.2026 00:10

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MAGNETOM Amira

MDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Shenzhen Magnetic Resonance Ltd.
Manufacturer SRN: CN-MF-000013436
UDI-DI: 04056869006819
Basic UDI-DI: 0405686900126US
Reference: 10836777
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: Germany
Authorised representative: Siemens Healthcare GmbH
Last updated: 16.07.2026 00:10

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MAGNETOM Aera

MDR_02_IIa_ERLN H 127_ACDV_Magnetom

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869006697
Basic UDI-DI: 0405686900125UQ
Reference: 10432914
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:10

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PROCURE

588SI1501

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: ScanMed LLC
Manufacturer SRN: US-MF-000011107
UDI-DI: 00859193006210
Basic UDI-DI: 0085919300588SI150122
Reference: 588SI1501
EMDN: Z11059080
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 22:38

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PROCURE

588SI3001

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: ScanMed LLC
Manufacturer SRN: US-MF-000011107
UDI-DI: 00859193006005
Basic UDI-DI: 0085919300588SI3001ZL
Reference: 588SI3001
EMDN: Z11059080
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 22:38

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Kryptonite Solutions

KIBM101

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Kryptonite Solutions
Manufacturer SRN: IN-MF-000032766
UDI-DI: G408INBOREMRISYSTEM0
Basic UDI-DI: ++G408INBORE01LEDMRIGF
Reference: KIBM101
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: France
Authorised representative: Mars Medical
Last updated: 15.07.2026 20:42

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Olea Sphere V3.0

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Olea Medical S.A.S.
Manufacturer SRN: FR-MF-000002403
UDI-DI: +EOLEOLEASPHEREV3P00
Basic UDI-DI: ++EOLEOLEASPHEREA3
Reference: MOD001;MOD002;MOD003;MOD004;MOD005;MOD007;MOD008;MOD010;MOD011;MOD012;MOD013;MOD014;MOD015;MOD016;MOD017;MOD020;MOD021
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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Olea S.I.A. Neurovascular V1.0

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Olea Medical S.A.S.
Manufacturer SRN: FR-MF-000002403
UDI-DI: +EOLENEUROVASV1P00
Basic UDI-DI: ++EOLENEUROVAS8M
Reference: AP-NV-FR-CT;AP-NV-FR-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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Neurovascular Insight V1.0

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Olea Medical S.A.S.
Manufacturer SRN: FR-MF-000002403
UDI-DI: +EOLENEUROVASIV1P00
Basic UDI-DI: ++EOLENEUROVASINSIGHTE7
Reference: AP-NVI-CT; AP-NVI-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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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

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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

Manufacturer products View details

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

MyoStrain

Class IIaMDR 2017/745On the marketDirect markingMeasuring function

Manufacturer: Myocardial Solutions, Inc.
Manufacturer SRN: US-MF-000018411
UDI-DI: +B672MYOSTRAIN060/$$053501X
Basic UDI-DI: ++B672MYOSTRAIN2Q
Reference: MyoStrain 6.1
EMDN: Z11059092
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

VitruvianScan

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Perspectum Ltd
Manufacturer SRN: GB-MF-000016685
UDI-DI: +B554VSMD10/$+ 000N
Basic UDI-DI: ++B554VSMUK
Reference: NA
EMDN: Z11059082
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Perspectum Unipessoal Lda
Last updated: 15.07.2026 14:49

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LiverMultiScan

LiverMultiScan v5

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Perspectum Ltd
Manufacturer SRN: GB-MF-000016685
UDI-DI: +B554LMS50D
Basic UDI-DI: ++B554LMSST
Reference: LiverMultiScan v5
EMDN: Z11059082
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Portugal
Authorised representative: Perspectum Unipessoal Lda
Last updated: 15.07.2026 14:49

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Hepatica

Hepatica v1

Class IIbMDR 2017/745No longer on the marketMeasuring function

Manufacturer: Perspectum Ltd
Manufacturer SRN: GB-MF-000016685
UDI-DI: +B554HEPATICA10U
Basic UDI-DI: ++B554HepaticaH2
Reference: v1
EMDN: Z11059082
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Portugal
Authorised representative: Perspectum Unipessoal Lda
Last updated: 15.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details