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AI-Rad Companion (Pulmonary)

MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT-Pulmo

Class IIbMDR 2017/745No longer on the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869996172
Basic UDI-DI: 0405686902222V5
Reference: 11665780
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:39

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AI-Rad Companion Prostate MR

MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_MR-P

Class IIbMDR 2017/745No longer on the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869298191
Basic UDI-DI: 0405686902009V3
Reference: 11582981
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

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syngo.via WebViewer

MDR_05_FOR_SYNGO_SaMD_IIb

Class IIbMDR 2017/745No longer on the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869237626
Basic UDI-DI: 0405686901978WU
Reference: 11461434
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

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Modality Viewer VA1

Image Processing Software_10_IIa_HES

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Medical Solutions USA, Inc.
Manufacturer SRN: US-MF-000016485
UDI-DI: 04056869247380
Basic UDI-DI: 0405686900137UX
Reference: VA1
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
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

Symbia.net

Nuclear Medicine Workstation_10_IIa_HES

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Medical Solutions USA, Inc.
Manufacturer SRN: US-MF-000016485
UDI-DI: 04056869002323
Basic UDI-DI: 0405686900136UV
Reference: 10520828
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Netherlands
Authorised representative: Siemens Healthcare GmbH
Last updated: 16.07.2026 00:10

Manufacturer products Authorised representative products Authorised representative actors View details

CS 7600

CS 7x00

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Carestream Dental LLC
Manufacturer SRN: US-MF-000003727
UDI-DI: 60192155942730
Basic UDI-DI: 01921557X00PP
Reference: 5942735
EMDN: Z11060201
EMDN description: SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS
First on market country: France
Authorised representative: TROPHY
Last updated: 15.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

CS 7200

CS 7200 IMAGING PLATE

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Carestream Dental LLC
Manufacturer SRN: US-MF-000003727
UDI-DI: 60192155942723
Basic UDI-DI: 01921557200HW
Reference: 5942727
EMDN: Z11060201
EMDN description: SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS
First on market country: France
Authorised representative: TROPHY
Last updated: 15.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

Imaging Plate

IMAGING PLATE #0

Class IIaMDR 2017/745On the market

Manufacturer: Carestream Dental LLC
Manufacturer SRN: US-MF-000003727
UDI-DI: 40192155942583
Basic UDI-DI: 0192155IMAGINGPLATEZP
Reference: 5942586
EMDN: Z11060280
EMDN description: DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: TROPHY
Last updated: 15.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

CSD Smart Plate

Class IIaMDR 2017/745On the market

Manufacturer: Carestream Dental LLC
Manufacturer SRN: US-MF-000003727
UDI-DI: 40192155942514
Basic UDI-DI: 0192155SmartplateTJ
Reference: 5942511
EMDN: Z11060280
EMDN description: DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: TROPHY
Last updated: 15.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

syngo.MI Cardiology

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Medical Solutions USA, Inc.
Manufacturer SRN: US-MF-000016485
UDI-DI: 04056869257044
Basic UDI-DI: 0405686900137UX
Reference: 11431538
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: -
Authorised representative: Siemens Healthcare GmbH
Last updated: 15.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

syngo.MI Cardiology

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Medical Solutions USA, Inc.
Manufacturer SRN: US-MF-000016485
UDI-DI: 04056869279763
Basic UDI-DI: 0405686900137UX
Reference: 11431548
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: -
Authorised representative: Siemens Healthcare GmbH
Last updated: 15.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Belle 1K

Class IMDR 2017/745On the marketActive device

Manufacturer: BelleTorus Corporation
Manufacturer SRN: US-MF-000034640
UDI-DI: *+G456BELLE1KV1D00/$$7SP0A*
Basic UDI-DI: ++G456BELLE1KU7
Reference: Belle 1K V1.0
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: Belle Europe SAS
Last updated: 15.07.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

eArchive

RISPACS

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Exprivia S.p.A.
Manufacturer SRN: IT-MF-000050463
UDI-DI: *+G266DWR0E*
Basic UDI-DI: ++G266PACSRCS3K
Reference: DWR
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 20:20

Manufacturer products View details

D835CODX1

coDiagnostiX

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Dental Wings GmbH
Manufacturer SRN: DE-MF-000006867
UDI-DI: D835CODX1
Basic UDI-DI: ++D835CODXDT
Reference: CDX-001-MD
EMDN: Z11069005
EMDN description: DIAGNOSTIC IMAGING WORKSTATIONS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 18:20

Manufacturer products View details

SICAT IMPLANT V2.0.40

Dental Implant Planning Software

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: SICAT GmbH & Co. KG
Manufacturer SRN: DE-MF-000005604
UDI-DI: D776IMPLANTV20400
Basic UDI-DI: ++D776IMPLANT8F
Reference: 10251701
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 18:10

Manufacturer products View details

SICAT FUNCTION V2.0.40

SICAT FUNCTION

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: SICAT GmbH & Co. KG
Manufacturer SRN: DE-MF-000005604
UDI-DI: D776FUNCTIONV20400
Basic UDI-DI: ++D776FUNCTIONGM
Reference: 10260501
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 18:10

Manufacturer products View details

SICAT ENDO V2.0.40

SICAT ENDO

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: SICAT GmbH & Co. KG
Manufacturer SRN: DE-MF-000005604
UDI-DI: D776ENDOV20400
Basic UDI-DI: ++D776ENDOEY
Reference: 10280501
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 18:10

Manufacturer products View details

SICAT AIR V2.0.40

SICAT Air

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: SICAT GmbH & Co. KG
Manufacturer SRN: DE-MF-000005604
UDI-DI: D776AIRV20400
Basic UDI-DI: ++D776AIRTN
Reference: 10271501
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 18:10

Manufacturer products View details

Veye Lung Nodules

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Aidence B.V.
Manufacturer SRN: NL-MF-000000534
UDI-DI: B865VEYELUNGNOD0307X0
Basic UDI-DI: ++B865VeyeLungNodules4H
Reference: 3
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 15.07.2026 15:02

Manufacturer products View details

Veye Engine

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Aidence B.V.
Manufacturer SRN: NL-MF-000000534
UDI-DI: B865VEYEENGINE0106X0
Basic UDI-DI: ++B865VeyeEngineME
Reference: 1
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 15.07.2026 15:02

Manufacturer products View details