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03.08.2026 02:01

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588 device results listed.

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TruSPECT

Class IIbMDR 2017/745Not intended for EU marketDirect marking

Manufacturer: Spectrum Dynamics Medical SA
Manufacturer SRN: CH-MF-000032669
UDI-DI: 07649991184103
Basic UDI-DI: 7649991184TruSPECT6J
Reference: 8010290-01
EMDN: Z11029082
EMDN description: VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: SPECTRUM DYNAMICS MEDICAL FRANCE SAS
Last updated: 03.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-SPECT CARDIO

Model 004

Class IIaMDR 2017/745Not intended for EU marketDirect marking

Manufacturer: Spectrum Dynamics Medical SA
Manufacturer SRN: CH-MF-000032669
UDI-DI: 07649991184080
Basic UDI-DI: 7649991184D-SPECTYM
Reference: 8010121-01
EMDN: Z11020104
EMDN description: FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION
First on market country: -
Authorised representative: SPECTRUM DYNAMICS MEDICAL FRANCE SAS
Last updated: 03.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

VERITON CT 264

VERITON CT

Class IIbMDR 2017/745Not intended for EU marketDirect marking

Manufacturer: Spectrum Dynamics Medical SA
Manufacturer SRN: CH-MF-000032669
UDI-DI: 07649991184028
Basic UDI-DI: 7649991184VERITON-CTRN
Reference: 8010142-01
EMDN: Z11020201
EMDN description: CT/GAMMA CAMERA SYSTEMS
First on market country: -
Authorised representative: SPECTRUM DYNAMICS MEDICAL FRANCE SAS
Last updated: 03.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

VERITON NM

001

Class IIaMDR 2017/745Not intended for EU marketDirect marking

Manufacturer: Spectrum Dynamics Medical SA
Manufacturer SRN: CH-MF-000032669
UDI-DI: 07649991184011
Basic UDI-DI: 7649991184VERITONLU
Reference: 8010184-01
EMDN: Z11020105
EMDN description: FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITH ‘TOTAL BODY’ ACQUISITION
First on market country: -
Authorised representative: SPECTRUM DYNAMICS MEDICAL FRANCE SAS
Last updated: 03.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

TruSPECT

Class IIbMDR 2017/745On the marketDirect marking

Manufacturer: Spectrum Dynamics Medical ltd
Manufacturer SRN: IL-MF-000013887
UDI-DI: 07290108670233
Basic UDI-DI: 729010867TruSPECTED
Reference: 8010290-01
EMDN: Z11029082
EMDN description: VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: SPECTRUM DYNAMICS MEDICAL FRANCE SAS
Last updated: 03.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

VERITON CT 264

VERITON CT

Class IIbMDR 2017/745On the marketDirect marking

Manufacturer: Spectrum Dynamics Medical ltd
Manufacturer SRN: IL-MF-000013887
UDI-DI: 07290108670110
Basic UDI-DI: 729010867VERITONCT22
Reference: 8010142-01
EMDN: Z11020201
EMDN description: CT/GAMMA CAMERA SYSTEMS
First on market country: France
Authorised representative: SPECTRUM DYNAMICS MEDICAL FRANCE SAS
Last updated: 03.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

VERITON NM 200

VERITON NM

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Spectrum Dynamics Medical ltd
Manufacturer SRN: IL-MF-000013887
UDI-DI: 07290108670103
Basic UDI-DI: 729010867VERITONXF
Reference: 8010184-01
EMDN: Z11020105
EMDN description: FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITH ‘TOTAL BODY’ ACQUISITION
First on market country: Austria
Authorised representative: SPECTRUM DYNAMICS MEDICAL FRANCE SAS
Last updated: 03.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-SPECT CARDIO

Model 004 (CARDIO) / Model 002 (VISTA)

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Spectrum Dynamics Medical ltd
Manufacturer SRN: IL-MF-000013887
UDI-DI: 07290108670073
Basic UDI-DI: 729010867DSPECTFJ
Reference: 8010121-01
EMDN: Z11020104
EMDN description: FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION
First on market country: Germany
Authorised representative: SPECTRUM DYNAMICS MEDICAL FRANCE SAS
Last updated: 03.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

CardioGraphe

SpotLight and CardioGraphe family of products

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Arineta
Manufacturer SRN: IL-MF-000028266
UDI-DI: 07290016484007
Basic UDI-DI: 7290016484SLG5
Reference: 07290016484007
EMDN: Z11020301
EMDN description: CT/PET SYSTEMS
First on market country: Northern Ireland
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

nordicAktiva

2.0

Class IMDR 2017/745On the marketDirect marking

Manufacturer: NordicNeuroLab AS
Manufacturer SRN: NO-MF-000000555
UDI-DI: 07090042059060
Basic UDI-DI: 7090042059218A
Reference: 2.0
EMDN: Z11020782
EMDN description: INTEGRATED MRI/PET SYSTEMS - SOFTWARE ACCESSORIES
First on market country: Norway
Authorised representative: -
Last updated: 03.07.2026 01:15

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nordicAktiva

1.3

Class IMDR 2017/745No longer on the marketActive deviceDirect marking

Manufacturer: NordicNeuroLab AS
Manufacturer SRN: NO-MF-000000555
UDI-DI: 07090042059022
Basic UDI-DI: 70900420592088
Reference: 1.3
EMDN: Z11020782
EMDN description: INTEGRATED MRI/PET SYSTEMS - SOFTWARE ACCESSORIES
First on market country: Norway
Authorised representative: -
Last updated: 03.07.2026 01:15

Manufacturer products View details

SyncBox

3.2

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NordicNeuroLab AS
Manufacturer SRN: NO-MF-000000555
UDI-DI: 07090042054058
Basic UDI-DI: 7090042054107C
Reference: 3.2
EMDN: Z11020780
EMDN description: INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES
First on market country: Norway
Authorised representative: -
Last updated: 03.07.2026 01:15

Manufacturer products View details

ResponseGrips

4.0

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NordicNeuroLab AS
Manufacturer SRN: NO-MF-000000555
UDI-DI: 07090042054010
Basic UDI-DI: 7090042054207F
Reference: 4.0
EMDN: Z11020780
EMDN description: INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES
First on market country: Norway
Authorised representative: -
Last updated: 03.07.2026 01:15

Manufacturer products View details

nordicAudio BatteryBox

1.0

Class IMDR 2017/745No longer on the marketActive deviceDirect marking

Manufacturer: NordicNeuroLab AS
Manufacturer SRN: NO-MF-000000555
UDI-DI: 07090042053051
Basic UDI-DI: 70900420530074
Reference: 102124
EMDN: Z11020780
EMDN description: INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES
First on market country: Norway
Authorised representative: -
Last updated: 03.07.2026 01:15

Manufacturer products View details

VisualSystem HD

1.2

Class IMDR 2017/745No longer on the marketActive deviceDirect marking

Manufacturer: NordicNeuroLab AS
Manufacturer SRN: NO-MF-000000555
UDI-DI: 07090042052108
Basic UDI-DI: 7090042052006X
Reference: 900005
EMDN: Z11020780
EMDN description: INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES
First on market country: Norway
Authorised representative: -
Last updated: 03.07.2026 01:15

Manufacturer products View details

Control Room Interface (CRI)

VSHD 1.3

Class IMDR 2017/745No longer on the marketActive deviceDirect marking

Manufacturer: NordicNeuroLab AS
Manufacturer SRN: NO-MF-000000555
UDI-DI: 07090042052061
Basic UDI-DI: 7090042052016Z
Reference: 900005
EMDN: Z11020780
EMDN description: INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES
First on market country: Norway
Authorised representative: -
Last updated: 03.07.2026 01:15

Manufacturer products View details

Symbia_Evo

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Medical Solutions USA, Inc.
Manufacturer SRN: US-MF-000016485
UDI-DI: 04056869001258
Basic UDI-DI: 0405686900134UR
Reference: 10910500
EMDN: Z11020105
EMDN description: FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITH ‘TOTAL BODY’ ACQUISITION
First on market country: -
Authorised representative: Siemens Healthcare GmbH
Last updated: 02.07.2026 22:32

Manufacturer products Authorised representative products Authorised representative actors View details

NeuWise PET/CT

Positron Emission Tomography (PET) and Computed Tomography (CT) System

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Shenyang Intelligent Neuclear Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000038118
UDI-DI: 06976302230022
Basic UDI-DI: 69763022300000000000000T3
Reference: none
EMDN: Z11020301
EMDN description: CT/PET SYSTEMS
First on market country: Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 02.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

06974197600678

uAI PET Neurology

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shanghai United Imaging Intelligence Co., Ltd.
Manufacturer SRN: CN-MF-000035682
UDI-DI: 06974197600678
Basic UDI-DI: 697419760PETNeurologyJQ
Reference: AI303006
EMDN: Z11020392
EMDN description: INTEGRATED CT/PET SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

06974197600371

uAI MI Oncology

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shanghai United Imaging Intelligence Co., Ltd.
Manufacturer SRN: CN-MF-000035682
UDI-DI: 06974197600371
Basic UDI-DI: 697419760MIOncologyND
Reference: AI303002
EMDN: Z11020392
EMDN description: INTEGRATED CT/PET SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: Malta
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details