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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

Brainlab Elements Contouring, 4.0

Brainlab Elements Contouring

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Brainlab SE
Manufacturer SRN: DE-MF-000006183
UDI-DI: 04056481143015
Basic UDI-DI: 4056481ContouringZQ
Reference: 04056481143015
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:30

Manufacturer products View details

Brainlab Elements Fibertracking, 2.0

Brainlab Elements Fibertracking

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Brainlab SE
Manufacturer SRN: DE-MF-000006183
UDI-DI: 04056481142186
Basic UDI-DI: 4056481BLElements9Y
Reference: 04056481142186
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:30

Manufacturer products View details

iRIS PACS

Class IMDR 2017/745On the market

Manufacturer: INFOMEDICA za proizvodnju i promet medicinskim proizvodima, društvo s ograničenom odgovornošću
Manufacturer SRN: HR-MF-000035358
UDI-DI: 03857500135612
Basic UDI-DI: 38575001356IPK1V5
Reference: IPK11000
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Croatia
Authorised representative: -
Last updated: 01.07.2026 16:32

Manufacturer products View details

Rayvolve

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: AZmed
Manufacturer SRN: FR-MF-000014277
UDI-DI: 37700180710082
Basic UDI-DI: 3770018071008VP
Reference: Rayvolve- On premise (Version 2)
EMDN: Z11060282
EMDN description: DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:01

Manufacturer products View details

inHEART Models AI

Class IIaMDR 2017/745On the marketActive device

Manufacturer: inHEART
Manufacturer SRN: FR-MF-000006723
UDI-DI: 03770019599167
Basic UDI-DI: 3770019599AIv16J
Reference: v3
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:58

Manufacturer products View details

inHEART Models Shaper

Class IIaMDR 2017/745On the marketActive device

Manufacturer: inHEART
Manufacturer SRN: FR-MF-000006723
UDI-DI: 03770019599044
Basic UDI-DI: 3770019599Shaperv1RU
Reference: v1
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:58

Manufacturer products View details

37603642100158

PACS

Class IMDR 2017/745On the marketActive device

Manufacturer: ENOVACOM
Manufacturer SRN: FR-MF-000000686
UDI-DI: 37603642100158
Basic UDI-DI: 376036421PACSAX
Reference: PACS (LIC-PACS*)
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:40

Manufacturer products View details

Ultima Burner

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