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Biograph Trinion.X EP9 CT64

PET-CT_11_IIb_HES

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Medical Solutions USA, Inc.
Manufacturer SRN: US-MF-000016485
UDI-DI: 04068151048070
Basic UDI-DI: 0405686900133UP
Reference: 11713857
EMDN: Z11020301
EMDN description: CT/PET SYSTEMS
First on market country: France
Authorised representative: Siemens Healthcare GmbH
Last updated: 05.08.2026 15:42

Manufacturer products Authorised representative products Authorised representative actors View details

Corridor4DM

Corridor4DM v2017; Corridor4DM v2018; Corridor4DM v2023; Corridor4DM v2024; Corridor4DM v2025

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: INVIA
Manufacturer SRN: US-MF-000008976
UDI-DI: 00864974000257
Basic UDI-DI: B-00864974000257
Reference: Corridor4DM
EMDN: Z11029092
EMDN description: VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: MedEnvoy Global BV
Last updated: 05.08.2026 01:22

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: 07090042059091
Basic UDI-DI: 7090042059218A
Reference: 800059
EMDN: Z11020782
EMDN description: INTEGRATED MRI/PET SYSTEMS - SOFTWARE ACCESSORIES
First on market country: Norway
Authorised representative: -
Last updated: 04.08.2026 22:25

Manufacturer products View details

Biograph mCT X - 3R combination

MDR_SPPP_11_IIb_HES_Comb.PET-CT

Class IIbMDR 2017/745On the marketNo EU rep

Manufacturer: Siemens Medical Solutions USA, Inc.
Manufacturer SRN: US-PR-000020471
UDI-DI: 04056869979908
Basic UDI-DI: 0405686902226VD
Reference: 11521498
EMDN: Z11020301
EMDN description: CT/PET SYSTEMS
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 20:57

Manufacturer products View details

Symbia Pro.specta X3

SPECT-CT_10_IIb_HES

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Medical Solutions USA, Inc.
Manufacturer SRN: US-MF-000016485
UDI-DI: 04056869264752
Basic UDI-DI: 0405686900135UT
Reference: 11364752
EMDN: Z11020201
EMDN description: CT/GAMMA CAMERA SYSTEMS
First on market country: Germany
Authorised representative: Siemens Healthcare GmbH
Last updated: 04.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Rozplňovací stanice

Class IMDR 2017/745On the marketActive deviceAdministering medicineDirect markingMeasuring function

Manufacturer: Lynax s.r.o.
Manufacturer SRN: CZ-MF-000034349
UDI-DI: 08594216370047
Basic UDI-DI: 859421637ROZUQ
Reference: N/A
EMDN: Z11029005
EMDN description: AUTOMATIC DOSE CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 01.08.2026 18:35

Manufacturer products View details

PLANET Onco Dose

Class IIbMDDOn the marketActive device

Manufacturer: DOSISOFT
Manufacturer SRN: FR-MF-000014706
UDI-DI: +B501PLANET0301020
Basic UDI-DI: B-+B501PLANET0301020
Reference: PL1100
EMDN: Z11020392
EMDN description: INTEGRATED CT/PET SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.08.2026 01:57

Manufacturer products View details

PLANET Onco Dose

Class IIbMDDOn the marketActive device

Manufacturer: DOSISOFT
Manufacturer SRN: FR-MF-000014706
UDI-DI: +B501PLANET0301010
Basic UDI-DI: B-+B501PLANET0301010
Reference: PL1100
EMDN: Z11020392
EMDN description: INTEGRATED CT/PET SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.08.2026 01:57

Manufacturer products View details

DynamicIQ

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278493323
Basic UDI-DI: 8406821BUG00218H9
Reference: 5882427
EMDN: Z11020492
EMDN description: POSITRON EMISSION TOMOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:17

Manufacturer products View details

MyoSPECT

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems Israel, Functional Imaging
Manufacturer SRN: IL-MF-000003062
UDI-DI: 00195278488619
Basic UDI-DI: 8406821BUG00251H7
Reference: H3912BC
EMDN: Z11020104
EMDN description: FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION
First on market country: Portugal
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

InroomViewingDevice

3.1

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NordicNeuroLab AS
Manufacturer SRN: NO-MF-000000555
UDI-DI: 07090042051064
Basic UDI-DI: 7090042051006S
Reference: 900030
EMDN: Z11020780
EMDN description: INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES
First on market country: Norway
Authorised representative: -
Last updated: 31.07.2026 21:55

Manufacturer products View details

Campo

Precision 128

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Liaoning Campo Imaging Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000011455
UDI-DI: 06975180870030
Basic UDI-DI: 6975180870002BR
Reference: 100120315001
EMDN: Z11020201
EMDN description: CT/GAMMA CAMERA SYSTEMS
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:43

Manufacturer products Authorised representative products Authorised representative actors View details

Campo

Precision 32

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Liaoning Campo Imaging Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000011455
UDI-DI: 06975180870023
Basic UDI-DI: 6975180870001BP
Reference: 100110315001
EMDN: Z11020201
EMDN description: CT/GAMMA CAMERA SYSTEMS
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:43

Manufacturer products Authorised representative products Authorised representative actors View details

RFT

10-F34743

Class IMDR 2017/745On the market

Manufacturer: Shenzhen RF Tech Co., Ltd.
Manufacturer SRN: CN-MF-000010149
UDI-DI: 06938146600256
Basic UDI-DI: 69381466FLX10F4743NC
Reference: 10-F34743
EMDN: Z11020780
EMDN description: INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Casus Europe B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

RFT

10-F34742

Class IMDR 2017/745On the market

Manufacturer: Shenzhen RF Tech Co., Ltd.
Manufacturer SRN: CN-MF-000010149
UDI-DI: 06938146600249
Basic UDI-DI: 69381466FLX10F4742NA
Reference: 10-F34742
EMDN: Z11020780
EMDN description: INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Casus Europe B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

RFT

10-F34744

Class IMDR 2017/745On the market

Manufacturer: Shenzhen RF Tech Co., Ltd.
Manufacturer SRN: CN-MF-000010149
UDI-DI: 06938146600232
Basic UDI-DI: 69381466FLX10F4744L7F
Reference: 10-F34744
EMDN: Z11020780
EMDN description: INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Casus Europe B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

RFT

10-F34722

Class IMDR 2017/745On the market

Manufacturer: Shenzhen RF Tech Co., Ltd.
Manufacturer SRN: CN-MF-000010149
UDI-DI: 06938146600225
Basic UDI-DI: 69381466R10H10F347285
Reference: 10-F34722
EMDN: Z11020780
EMDN description: INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Casus Europe B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

RFT

10-F35782

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen RF Tech Co., Ltd.
Manufacturer SRN: CN-MF-000010149
UDI-DI: 06938146600195
Basic UDI-DI: 69381466GEM10F5782LSU
Reference: 10-F35782
EMDN: Z11020780
EMDN description: INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Casus Europe B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

RFT

10-F35781

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen RF Tech Co., Ltd.
Manufacturer SRN: CN-MF-000010149
UDI-DI: 06938146600188
Basic UDI-DI: 69381466GEM10F5781MST
Reference: 10-F35781
EMDN: Z11020780
EMDN description: INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Casus Europe B.V.
Last updated: 31.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

RFT

10-F35780

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen RF Tech Co., Ltd.
Manufacturer SRN: CN-MF-000010149
UDI-DI: 06938146600171
Basic UDI-DI: 69381466GEM10F5780LSN
Reference: 10-F35780
EMDN: Z11020780
EMDN description: INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Casus Europe B.V.
Last updated: 31.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details