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08800045800007

VN-M-01

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: VUNO Inc.
Manufacturer SRN: KR-MF-000022266
UDI-DI: 08800045800007
Basic UDI-DI: 88000458VBAXP
Reference: VN-M-01
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Türkiye
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

GEMPACS

Class IMDR 2017/745On the marketActive device

Manufacturer: DRGEM Corporation
Manufacturer SRN: KR-MF-000017990
UDI-DI: 08800011170028
Basic UDI-DI: 88000111RPSGEM6000P2
Reference: GEMPACS
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

08720892617644

Lumi Calculation Functions

Class IMDR 2017/745On the marketDirect markingMeasuring function

Manufacturer: Augmedit B.V.
Manufacturer SRN: NL-MF-000045948
UDI-DI: 08720892617644
Basic UDI-DI: 87208926176LumiCFEM
Reference: 01
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 20:08

Manufacturer products View details

Lumi Referenced

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Augmedit B.V.
Manufacturer SRN: NL-MF-000045948
UDI-DI: 08720892617620
Basic UDI-DI: 87208926176LumiRef8J
Reference: 01
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 20:08

Manufacturer products View details

Lumi Segment

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Augmedit B.V.
Manufacturer SRN: NL-MF-000045948
UDI-DI: 08720892617613
Basic UDI-DI: 87208926176LumiSegmentN7
Reference: 01
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 20:08

Manufacturer products View details

Lumi Prepare

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Augmedit B.V.
Manufacturer SRN: NL-MF-000045948
UDI-DI: 08720892617606
Basic UDI-DI: 87208926176LumiPrepareQN
Reference: 01
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 20:08

Manufacturer products View details

VisiQuick

Class IMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Citodent Imaging B.V.
Manufacturer SRN: NL-MF-000000754
UDI-DI: 08720299734302
Basic UDI-DI: 872029973431001QQ
Reference: VisiQuick
EMDN: Z11060292
EMDN description: DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:49

Manufacturer products View details

Untire

Class IMDR 2017/745On the marketActive device

Manufacturer: Tired of Cancer BV
Manufacturer SRN: NL-MF-000000800
UDI-DI: 08720299218024
Basic UDI-DI: 87202992180UntireFU
Reference: 08720299218024
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:47

Manufacturer products View details

EVOCS

Class IMDR 2017/745On the marketActive device

Manufacturer: Fysicon B.V.
Manufacturer SRN: NL-MF-000002694
UDI-DI: 08720254542751
Basic UDI-DI: 8719689142EVOCSP8
Reference: 010147xxx
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:39

Manufacturer products View details

NEGATOSKOP(SINGLE)

NEGATOSCOPE

Class IMDR 2017/745On the marketDirect marking

Manufacturer: TUR-MED HASTANE MALZ. SAN. TIC. LTD. ŞTI.
Manufacturer SRN: TR-MF-000018608
UDI-DI: 08698943381120
Basic UDI-DI: 869894338NGTSZU
Reference: TM-F 6003
EMDN: Z11069005
EMDN description: DIAGNOSTIC IMAGING WORKSTATIONS
First on market country: Romania
Authorised representative: -
Last updated: 03.07.2026 18:57

Manufacturer products View details

Med X-Ray 7.1

Class IIaNot specifiedOn the marketActive deviceDirect marking

Manufacturer: MED.e.Com
Manufacturer SRN: FR-MF-000003036
UDI-DI: 03665587000170
Basic UDI-DI: 3665587ACQUISITION00001YU
Reference: XR.7.1
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 03.07.2026 18:24

Manufacturer products View details

CARPL

Class IMDR 2017/745On the marketActive device

Manufacturer: CARPL.ai Inc.
Manufacturer SRN: US-MF-000044270
UDI-DI: 00860012916306
Basic UDI-DI: 8600129163V2CF
Reference: CARPL
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Freyr Life Sciences GmbH
Last updated: 03.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

00860010618196

VECTRA WB360

Class IMDR 2017/745On the marketActive device

Manufacturer: CANFIELD SCIENTIFIC Inc
Manufacturer SRN: US-MF-000042029
UDI-DI: 00860010618196
Basic UDI-DI: 8600106181VECTRAWB360V4
Reference: VECTRA WB360
EMDN: Z11069080
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE
First on market country: Italy
Authorised representative: CANFIELD SCIENTIFIC SRL
Last updated: 03.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

00860010618127

INTELLISTUDIO

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: CANFIELD SCIENTIFIC Inc
Manufacturer SRN: US-MF-000042029
UDI-DI: 00860010618127
Basic UDI-DI: 8600106181INTELLISTUDIOKN
Reference: INTELLISTUDIO
EMDN: Z11069080
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE
First on market country: Germany
Authorised representative: CANFIELD SCIENTIFIC SRL
Last updated: 03.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

System M2

Medirecord M2

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Medirecord CZ s.r.o.
Manufacturer SRN: CZ-MF-000049661
UDI-DI: 08594230260003
Basic UDI-DI: 859423026MDRSYSTEMM2XR
Reference: M2
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:53

Manufacturer products View details

MARIE PACS

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: OR-CZ spol. s r.o.
Manufacturer SRN: CZ-MF-000028433
UDI-DI: 08594212710014
Basic UDI-DI: 859421271MARIEPACSNL
Reference: MPACS-AAAA-MMRR
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:51

Manufacturer products View details

Dicompass Gateway

Dicompass

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: MEDORO s.r.o.
Manufacturer SRN: CZ-MF-000024306
UDI-DI: 08594212320015
Basic UDI-DI: 859421232DICOMPASSGM
Reference: 1
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:51

Manufacturer products View details

VXC 3DLFS MAX

3DLF Scanner Max-V2

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Voxelcare S.L
Manufacturer SRN: ES-MF-000048501
UDI-DI: 84370278160174
Basic UDI-DI: 84370278163DLFSMaxVX
Reference: 3D Laser Plantar Foot Scanner Max
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 15:19

Manufacturer products View details

3DLFS COMPACT

Compact X

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Voxelcare S.L
Manufacturer SRN: ES-MF-000048501
UDI-DI: 84370278160006
Basic UDI-DI: 84370278163DLFSCompactTY
Reference: 3D Laser Plantar Foot Scanner Compact
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 15:19

Manufacturer products View details

IRE IMAGE CHANNEL

Class IMDR 2017/745On the marketActive device

Manufacturer: IRE RAYOS X, S.A.
Manufacturer SRN: ES-MF-000001652
UDI-DI: 84370236260304
Basic UDI-DI: 8437023626030IICJZ
Reference: Catalogo IREA3_CATCOM_GEN_ED2024_1
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:18

Manufacturer products View details