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00195278707741

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Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Healthcare
Manufacturer SRN: US-MF-000001862
UDI-DI: 00195278707741
Basic UDI-DI: 08406821BUG004637C
Reference: 5941611
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Champion

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278707871
Basic UDI-DI: 8406821BUG00388J3
Reference: SIGNA Champion
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

BreView

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278715890
Basic UDI-DI: 8406821BUG00418HK
Reference: 5942367
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

FlightPlan for EVAR

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278923646
Basic UDI-DI: 8406821BUG00070GZ
Reference: 5970980
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

GenIQ

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278923660
Basic UDI-DI: 8406821BUG00072H5
Reference: 5970982
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

MR VesselIQ Xpress

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278923738
Basic UDI-DI: 8406821BUG00076HD
Reference: 5970990
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

PROView

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278923752
Basic UDI-DI: 8406821BUG00079HK
Reference: 5970991
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

READY View

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278923769
Basic UDI-DI: 8406821BUG00080H4
Reference: 5970992
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

VersaViewer

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278925541
Basic UDI-DI: 08406821BUG005267B
Reference: 5964976
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

SIGNA Sprint

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278929518
Basic UDI-DI: 08406821BUG0052579
Reference: SIGNA Sprint
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: Belgium
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

VersaViewer

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278931306
Basic UDI-DI: 08406821BUG005267B
Reference: 5973581
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

MBST® CLOSED·SYSTEM·300

MBST Magnetic Resonance Therapy Product Family

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: MedTec Medizintechnik GmbH
Manufacturer SRN: DE-MF-000009592
UDI-DI: 04065333007467
Basic UDI-DI: 40653330MBSTJR
Reference: 4065333007467
EMDN: Z11059099
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:21

Manufacturer products View details

Optistar

Class IIbMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: Liebel-Flarsheim Company, LLC
Manufacturer SRN: US-MF-000002605
UDI-DI: 10746190005988
Basic UDI-DI: 0746190L000025N
Reference: 814006
EMDN: Z11059001
EMDN description: MAGNETIC RESONANCE INJECTORS
First on market country: France
Authorised representative: Guerbet
Last updated: 30.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGNETOM Flow.Ace

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: 04068151047813
Basic UDI-DI: 0405686900126US
Reference: 11571131
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: 30.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

MAGNETOM Flow.Plus Z

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: 04068151017397
Basic UDI-DI: 0405686900131UK
Reference: 11571638
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: 30.07.2026 18:29

Manufacturer products View details

06970564410864

SYN. BODY COIL 1.5T

Class IIaMDDOn the marketActive device

Manufacturer: Shanghai Chenguang Medical Technologies Co., Ltd
Manufacturer SRN: CN-MF-000001299
UDI-DI: 06970564410864
Basic UDI-DI: B-06970564410864
Reference: 4598-000-51872
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

00850001088015

suiteHEART Software

Class IIaMDDOn the market

Manufacturer: NeoSoft LLC
Manufacturer SRN: US-MF-000007437
UDI-DI: 00850001088015
Basic UDI-DI: B-00850001088015
Reference: NS-02-046-0009
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

Taboret TB-MR

TB-MR

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Zakład Techniki Medycznej "Tech-Med" Sp. z o.o.
Manufacturer SRN: PL-MF-000009262
UDI-DI: 05904126018411
Basic UDI-DI: 5904126-TB-MR/9W
Reference: TB-05-MR
EMDN: Z11059099
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER
First on market country: Poland
Authorised representative: -
Last updated: 16.07.2026 10:11

Manufacturer products View details

AIRIS Vento

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04573596201008
Basic UDI-DI: 457359620103000000000032R
Reference: Joint coil(M) MR-JCR-102 for AIRIS Vento
EMDN: Z11050102
EMDN description: OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 16.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

APERTO Lucent

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04573596200957
Basic UDI-DI: 457359620103000000000052V
Reference: Head/Neck coil MR-MHC-81 for APERTO Lucent
EMDN: Z11050102
EMDN description: OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 16.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details