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Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2CoilTM) – Siemens

BPX 30 NG-S

Class IMDR 2017/745On the marketContains latexSingle use

Manufacturer: DxTx Medical, Inc.
Manufacturer SRN: US-MF-000026795
UDI-DI: 00850011472002
Basic UDI-DI: 0850011472BPX30NG-SJ8
Reference: BPX 30 NG-S
EMDN: Z1105018002
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY VOLUMETRIC COILS
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 16.07.2026 06:10

Manufacturer products Authorised representative products Authorised representative actors View details

00198953043387

MR Contour DL

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare
Manufacturer SRN: US-MF-000001862
UDI-DI: 00198953043387
Basic UDI-DI: 08406821BUG0059782
Reference: 5986345-001
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Prime Elite

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278601162
Basic UDI-DI: 08406821BUG004837J
Reference: SIGNA Prime Elite
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: Türkiye
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

WGS-100

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Ivy Biomedical Systems, Inc.
Manufacturer SRN: US-MF-000001164
UDI-DI: 00816396022614
Basic UDI-DI: 081639602WGS-100DD
Reference: 3684-03-01
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 04:21

Manufacturer products Authorised representative products Authorised representative actors View details

LungMaps

MDR_02_IIa_FOR AG S3_ACDV_SaMD

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthineers AG
Manufacturer SRN: DE-MF-000038456
UDI-DI: 04068151086584
Basic UDI-DI: 0405686902283VR
Reference: VA10A
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:39

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MAGNETOM Free.XL

MDR_02_IIa_FOR AG S3_ACDV_Magnetom

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthineers AG
Manufacturer SRN: DE-MF-000038456
UDI-DI: 04056869997094
Basic UDI-DI: 0405686902279W2
Reference: 11690226
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 00:39

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Chondral Quant

MDR_02_IIa_ERLN H 127_ACDV_SaMD

Class IIaMDR 2017/745On the market

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869964386
Basic UDI-DI: 0405686900128UW
Reference: VA10A
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:10

Manufacturer products View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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