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Resoundant Active Driver v2

RESYS4001

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Resoundant
Manufacturer SRN: US-MF-000037180
UDI-DI: 00850011790267
Basic UDI-DI: 0850011790RESYS400189
Reference: RESYS4001
EMDN: Z11059099
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER
First on market country: Germany
Authorised representative: VISAMED GmbH
Last updated: 16.07.2026 06:10

Manufacturer products Authorised representative products Authorised representative actors View details

Resoundant Pillow Passive Driver

REFPDAUX

Class IMDR 2017/745On the marketActive device

Manufacturer: Resoundant
Manufacturer SRN: US-MF-000037180
UDI-DI: 00850011790229
Basic UDI-DI: 0850011790REFPDAUXLP
Reference: REFPDAUX
EMDN: Z11059080
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: VISAMED GmbH
Last updated: 16.07.2026 06:10

Manufacturer products Authorised representative products Authorised representative actors View details

Resoundant Passive Driver, Rigid

REPD2000

Class IMDR 2017/745On the marketActive device

Manufacturer: Resoundant
Manufacturer SRN: US-MF-000037180
UDI-DI: 00850011790106
Basic UDI-DI: 0850011790REPD20008L
Reference: REPD2000
EMDN: Z11059080
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: VISAMED GmbH
Last updated: 16.07.2026 06:10

Manufacturer products Authorised representative products Authorised representative actors View details

Resoundant Flex Passive Driver, Small

REFPDS19

Class IMDR 2017/745On the marketActive device

Manufacturer: Resoundant
Manufacturer SRN: US-MF-000037180
UDI-DI: 00850011790052
Basic UDI-DI: 0850011790REFPDS19JC
Reference: REFPDS19
EMDN: Z11059080
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: VISAMED GmbH
Last updated: 16.07.2026 06:10

Manufacturer products Authorised representative products Authorised representative actors View details

Resoundant Flex Passive Driver, Large

REFPDL18

Class IMDR 2017/745On the marketActive device

Manufacturer: Resoundant
Manufacturer SRN: US-MF-000037180
UDI-DI: 00850011790045
Basic UDI-DI: 0850011790REFPDL18H7
Reference: REFPDL18
EMDN: Z11059080
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: VISAMED GmbH
Last updated: 16.07.2026 06:10

Manufacturer products Authorised representative products Authorised representative actors View details

Siemens 3.0T Endo Interface II with Tim 4G Slide Connect (e2CoilTM)

4000518

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DxTx Medical, Inc.
Manufacturer SRN: US-MF-000026795
UDI-DI: 00850011472255
Basic UDI-DI: 08500114724000518RE
Reference: 4000518
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
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

Siemens 1.5T Endo Interface (eCoil®)

7582385

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DxTx Medical, Inc.
Manufacturer SRN: US-MF-000026795
UDI-DI: 00850011472217
Basic UDI-DI: 085001147207582385VT
Reference: 7582385
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
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

Siemens 3.0T Endo Interface (eCoil®)

8624855

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DxTx Medical, Inc.
Manufacturer SRN: US-MF-000026795
UDI-DI: 00850011472187
Basic UDI-DI: 085001147208624855VM
Reference: 8624855
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
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

3.0T Ingenia Endorectal Coil Interface Device System (eCoil®)

Class IIaMDR 2017/745On the marketNo EU rep

Manufacturer: DxTx Medical, Inc.
Manufacturer SRN: US-PR-000042604
UDI-DI: 00850011472101
Basic UDI-DI: 0850011472989603019032S5
Reference: 9896-030-19032
EMDN: Z1105018002
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY VOLUMETRIC COILS
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 06:10

Manufacturer products View details

3.0T Ingenia Endorectal Coil Interface Device (eCoil®)

3043032

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DxTx Medical, Inc.
Manufacturer SRN: US-MF-000026795
UDI-DI: 00850011472095
Basic UDI-DI: 0850011472459800113812HF
Reference: 4598-001-13812
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
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

1.5T Ingenia Endorectal Coil Interface Device (eCoil®)

4598-001-13802

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DxTx Medical, Inc.
Manufacturer SRN: US-MF-000026795
UDI-DI: 00850011472019
Basic UDI-DI: 0850011472459800113802HC
Reference: 4598-001-13802
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
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

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

18ch T/R Knee Coil

MRI RF Coils

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Quality Electrodynamics, LLC
Manufacturer SRN: US-MF-000001417
UDI-DI: 00814848020003
Basic UDI-DI: 081484802RFCOILBV
Reference: Q7000074
EMDN: Z11059080
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

SureWave Elastography

MR Elastography

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Quality Electrodynamics, LLC
Manufacturer SRN: US-MF-000001417
UDI-DI: 00814848020775
Basic UDI-DI: 081484802MREH6
Reference: Q7000225
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

MEDRAD® MRXperion MR Injection System

Class IMDR 2017/745On the market

Manufacturer: Bayer Medical Care Inc.
Manufacturer SRN: US-MF-000007050
UDI-DI: 00616258021393
Basic UDI-DI: 0616258TFCN-0089I4G
Reference: MRXP PFA GY
EMDN: Z11059080
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Bayer Medical Care B.V.
Last updated: 16.07.2026 01:04

Manufacturer products Authorised representative products Authorised representative actors View details

MEDRAD® Spectris Solaris EP MR Injection System

Class IIbMDR 2017/745No longer on the market

Manufacturer: Bayer Medical Care Inc.
Manufacturer SRN: US-MF-000007050
UDI-DI: 00616258008745
Basic UDI-DI: 0616258TFCN-0049QL
Reference: 3012011
EMDN: Z11059001
EMDN description: MAGNETIC RESONANCE INJECTORS
First on market country: -
Authorised representative: Bayer Medical Care B.V.
Last updated: 16.07.2026 01:04

Manufacturer products Authorised representative products Authorised representative actors View details

MEDRAD® MRXperion MR Injection System

Class IIbMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: Bayer Medical Care Inc.
Manufacturer SRN: US-MF-000007050
UDI-DI: 00616258008134
Basic UDI-DI: 0616258TFCN-0089IIb2P
Reference: MRXP 200
EMDN: Z11059001
EMDN description: MAGNETIC RESONANCE INJECTORS
First on market country: Netherlands
Authorised representative: Bayer Medical Care B.V.
Last updated: 16.07.2026 01:04

Manufacturer products Authorised representative products Authorised representative actors View details