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Class IMDR 2017/745On the market

Manufacturer: PRO DATA S.r.l.
Manufacturer SRN: IT-MF-000029316
UDI-DI: 08054110360020
Basic UDI-DI: 805411036MPWB9Z
Reference: 02.XX
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 10:01

Manufacturer products View details

TRACE4AD™

TRACE4AD

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DeepTrace Technologies S.R.L.
Manufacturer SRN: IT-MF-000027591
UDI-DI: 08052015140198
Basic UDI-DI: 805201514TRACE4ADCLv2.52Z
Reference: 019
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:11

Manufacturer products View details

TRACE4OC™

TRACE4OC

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DeepTrace Technologies S.R.L.
Manufacturer SRN: IT-MF-000027591
UDI-DI: 08052015140167
Basic UDI-DI: 805201514TRACE4OCv2.175
Reference: 016
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:11

Manufacturer products View details

IPS CaseDesigner 2.3 for Windows 64-bit

Diagnostic and treatment software

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747185829
Basic UDI-DI: 733274700000016275
Reference: 300011_V2.3_WIN64
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details

DTX Studio Implant 3.6 for Win 64-bit

Diagnostic and treatment software

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747181937
Basic UDI-DI: 73327470000002206S
Reference: 300843_V3.6_WIN64
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details

DTX Studio Lab 1.12 for Windows 64-bit

Design software

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747180756
Basic UDI-DI: 73327470000002146X
Reference: 300607_V1.12_WIN64
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details

DS Core CBCT Anatomy

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Zetta25 AG
Manufacturer SRN: CH-MF-000022840
UDI-DI: 04262352350080
Basic UDI-DI: 426235235-S3816-000-XX
Reference: 04262352350080
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: DS REP B.V.
Last updated: 01.07.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

DI Scan

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Zetta25 AG
Manufacturer SRN: CH-MF-000022840
UDI-DI: 04262352350035
Basic UDI-DI: 426235235-S3806-002-XL
Reference: 04262352350035
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: DS REP B.V.
Last updated: 01.07.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

AIRAscore

Class IIaMDR 2017/745No longer on the marketActive deviceMeasuring function

Manufacturer: AIRAmed GmbH
Manufacturer SRN: DE-MF-000006413
UDI-DI: 04260723680040
Basic UDI-DI: 426072368AIRAscore2E
Reference: N/A
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:02

Manufacturer products View details

Origin Data Management, 3.1

Origin Data Management

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Brainlab SE
Manufacturer SRN: DE-MF-000006183
UDI-DI: 04056481145118
Basic UDI-DI: 4056481ODM31S2
Reference: 04056481145118
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:34

Manufacturer products View details

Buzz Virtual App, 1.1

Buzz Virtual App

Class IMDR 2017/745On the marketActive device

Manufacturer: Brainlab SE
Manufacturer SRN: DE-MF-000006183
UDI-DI: 04056481144265
Basic UDI-DI: 4056481BuzzVirtualAppV8
Reference: N/A
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:30

Manufacturer products View details

DICOM Proxy, 4.3

DICOM Proxy

Class IMDR 2017/745On the marketActive device

Manufacturer: Brainlab SE
Manufacturer SRN: DE-MF-000006183
UDI-DI: 04056481143527
Basic UDI-DI: 4056481DataManagementDD
Reference: N/A
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:30

Manufacturer products View details

DUOnco Bone v1

DUOnco Bone

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: INTRASENSE
Manufacturer SRN: FR-MF-000001551
UDI-DI: 03700719701102
Basic UDI-DI: 37007197DUOncoBoneJJ
Reference: DUOnco Bone v1
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 14:29

Manufacturer products View details

DUOnco Pancreas 1.0

DUOncoPancreas

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: INTRASENSE
Manufacturer SRN: FR-MF-000001551
UDI-DI: 03700719700716
Basic UDI-DI: 37007197DUOncoPancreas3E
Reference: DUOnco Pancreas 1.0
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 14:29

Manufacturer products View details

DTX Studio Clinic 4.7 for Win 64-bit

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747225501
Basic UDI-DI: 73327470000002206S
Reference: 300851_V4.7_WIN64
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 25.06.2026 22:47

Manufacturer products View details

DTX Studio Clinic 4.7 for Mac

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747225518
Basic UDI-DI: 73327470000002206S
Reference: 300851_V4.7_MAC
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 25.06.2026 22:47

Manufacturer products View details

Advanced Visualization Workspace

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838123168
Basic UDI-DI: 0884838BM1052LU
Reference: 881120
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 24.06.2026 22:44

Manufacturer products View details

NM Suite

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838128835
Basic UDI-DI: 0884838BM1027LV
Reference: 881090
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 24.06.2026 22:44

Manufacturer products View details

CT ASPECT Scoring

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838129993
Basic UDI-DI: 0884838BM1050LQ
Reference: 881093
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 24.06.2026 22:44

Manufacturer products View details

Helion

Class IMDR 2017/745On the marketActive device

Manufacturer: Videomed Srl
Manufacturer SRN: IT-MF-000024944
UDI-DI: 00615521031589
Basic UDI-DI: 0615521GMN1160018M
Reference: VR401113
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 17:17

Manufacturer products View details