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WorkstationOne

1.9.1

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Three Palm Software
Manufacturer SRN: US-MF-000002924
UDI-DI: B148WSONE1910
Basic UDI-DI: ++B148WSONE1919U
Reference: 1.9.1
EMDN: Z11069005
EMDN description: DIAGNOSTIC IMAGING WORKSTATIONS
First on market country: Italy
Authorised representative: Wellkang Ltd
Last updated: 15.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

WorkstationOne

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Three Palm Software
Manufacturer SRN: US-MF-000002924
UDI-DI: B148WSONE1900
Basic UDI-DI: ++B148WSONE1909S
Reference: 1.9.0
EMDN: Z11069005
EMDN description: DIAGNOSTIC IMAGING WORKSTATIONS
First on market country: Italy
Authorised representative: Wellkang Ltd
Last updated: 15.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

OPENSIGHT

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Novarad Corporation
Manufacturer SRN: US-MF-000028327
UDI-DI: B109OPENSIGHT188040
Basic UDI-DI: ++B109OPENSIGHTG3
Reference: 1.8804
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

NOVAPACS

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Novarad Corporation
Manufacturer SRN: US-MF-000028327
UDI-DI: B109NOVAPACS87110
Basic UDI-DI: ++B109NOVAPACS5H
Reference: 8.7.11
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

Synapse Mobility

RESMD-C

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: ResolutionMD, Inc.
Manufacturer SRN: CA-MF-000031810
UDI-DI: B037FFSMC0
Basic UDI-DI: ++B037RESMDCXM
Reference: FFSM-C
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: CEpartner4U
Last updated: 15.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

iQ-4VIEW 2.4

iQ-SYSTEM PACS

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: IMAGE Information Systems Europe GmbH
Manufacturer SRN: DE-MF-000004979
UDI-DI: +B403IQ4VIEW240-
Basic UDI-DI: ++B403IQSYSTEMPACS1YG
Reference: IQ4VIEW24
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:49

Manufacturer products View details

IntelePACS

5-X-X

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Intelerad Medical Systems Incorporated
Manufacturer SRN: CA-MF-000011834
UDI-DI: +B228INTELEPACS0
Basic UDI-DI: ++B228INTELEPACSSC
Reference: N/A
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

MedStation

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Exprivia S.p.A.
Manufacturer SRN: IT-MF-000050463
UDI-DI: *+G266MST0L*
Basic UDI-DI: ++G266PACSRCS3K
Reference: MST
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 14:46

Manufacturer products View details

eRis/eVisit

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Exprivia S.p.A.
Manufacturer SRN: IT-MF-000050463
UDI-DI: *+G266RCS09*
Basic UDI-DI: ++G266PACSRCS3K
Reference: RCS
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 14:46

Manufacturer products View details

eViewer

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Exprivia S.p.A.
Manufacturer SRN: IT-MF-000050463
UDI-DI: *+G266VWR0W*
Basic UDI-DI: ++G266PACSRCS3K
Reference: VWR
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 14:46

Manufacturer products View details

1118075961

PACScenter

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: BMD Software
Manufacturer SRN: PT-MF-000017663
UDI-DI: 1118075961
Basic UDI-DI: PP12458BMD.PC.10000202447
Reference: PACScenter
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Portugal
Authorised representative: -
Last updated: 15.07.2026 14:36

Manufacturer products View details

teamCRAFT5

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: Digithurst Bildverarbeitungssysteme GmbH & Co. KG
Manufacturer SRN: DE-MF-000006131
UDI-DI: D-teamCRAFT54U
Basic UDI-DI: B-teamCRAFT54U
Reference: 5.18
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:31

Manufacturer products View details

Viewmed Single

4.2.5

Class IMDDOn the market

Manufacturer: VIXIMED AB
Manufacturer SRN: SE-MF-000046510
UDI-DI: D-Viewmed-Single6N
Basic UDI-DI: B-Viewmed-Single6N
Reference: PRO04
EMDN: Z11069099
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 15.07.2026 13:27

Manufacturer products View details

TomoCon PACS

TomoCon PACS - versions: 25; 24; 23; 22; 21; 20; 19; 18.

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: TatraMed Software s.r.o.
Manufacturer SRN: SK-MF-000017681
UDI-DI: D-TomoCon-GL
Basic UDI-DI: B-TomoCon-GL
Reference: TomoCon PACS & Diagnostic stations
EMDN: Z11069005
EMDN description: DIAGNOSTIC IMAGING WORKSTATIONS
First on market country: Slovakia
Authorised representative: -
Last updated: 15.07.2026 11:25

Manufacturer products View details

D-TW-MF-000020401W2

SoliPACS Client Viewer；SoliPACS Server； SoliPACS Web Viewer； SoliPACS Gateway ；MobiPACS App ；Rad@

Class IIaMDDOn the marketActive device

Manufacturer: EBM Technologies Inc.
Manufacturer SRN: TW-MF-000020401
UDI-DI: D-TW-MF-000020401W2
Basic UDI-DI: B-TW-MF-000020401W2
Reference: IIa
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Ireland
Authorised representative: International Associates Auditing & Certification Limited
Last updated: 15.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-TW-MF-0000204011W3SX

EBM VS 1000 : EBM VS 2000

Class IIbMDDOn the marketActive device

Manufacturer: EBM Technologies Inc.
Manufacturer SRN: TW-MF-000020401
UDI-DI: D-TW-MF-0000204011W3SX
Basic UDI-DI: B-TW-MF-0000204011W3SX
Reference: IIb
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Ireland
Authorised representative: International Associates Auditing & Certification Limited
Last updated: 15.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

Trace4OC

TRACE4OC

Class IMDDOn the marketActive device

Manufacturer: DeepTrace Technologies S.R.L.
Manufacturer SRN: IT-MF-000027591
UDI-DI: D-TRACE4OCVF
Basic UDI-DI: B-TRACE4OCVF
Reference: 002
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 10:59

Manufacturer products View details

Trace4AD

TRACE4AD

Class IMDDOn the marketActive device

Manufacturer: DeepTrace Technologies S.R.L.
Manufacturer SRN: IT-MF-000027591
UDI-DI: D-TRACE4ADU7
Basic UDI-DI: B-TRACE4ADU7
Reference: 014, 031
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 10:59

Manufacturer products View details

TomoCon GO - versions 1.0, 2.0, 2.1, 2.2, 2.3, 2.4

Class IMDDOn the marketActive deviceMeasuring function

Manufacturer: TatraMed Software s.r.o.
Manufacturer SRN: SK-MF-000017681
UDI-DI: D-TGO-2-EN
Basic UDI-DI: B-TGO-2-EN
Reference: TomoCon GO
EMDN: Z11069005
EMDN description: DIAGNOSTIC IMAGING WORKSTATIONS
First on market country: Slovakia
Authorised representative: -
Last updated: 15.07.2026 10:58

Manufacturer products View details

RAPID Software

Rapid Software

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: iSchemaView, Inc.
Manufacturer SRN: US-MF-000040716
UDI-DI: D-RapidSoftwareY7
Basic UDI-DI: B-RapidSoftwareY7
Reference: N/A
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 05:33

Manufacturer products Authorised representative products Authorised representative actors View details