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G354

Photochemicals

Class IMDR 2017/745On the market

Manufacturer: Agfa NV
Manufacturer SRN: BE-MF-000000571
UDI-DI: 05414904000946
Basic UDI-DI: 5414904272985ZC
Reference: 2828Q
EMDN: Z11079085
EMDN description: VARIOUS X-RAY FILM IMAGING SUPPORT INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:52

Manufacturer products View details

Barco

surgical monitor

Class IMDR 2017/745On the marketActive device

Manufacturer: Barco, Inc.
Manufacturer SRN: US-MF-000018743
UDI-DI: 00700621719298
Basic UDI-DI: 5415334_Surgical-US_DL
Reference: 215EFOEU
EMDN: Z11900802
EMDN description: BIOIMAGING VIEWING MONITORS
First on market country: Belgium
Authorised representative: Barco NV
Last updated: 31.07.2026 10:49

Manufacturer products Authorised representative products Authorised representative actors View details

Mediadent

Mediadent V8

Class IIaMDR 2017/745On the marketDirect markingMeasuring function

Manufacturer: Corilus NV
Manufacturer SRN: BE-MF-000012721
UDI-DI: 05404032600002
Basic UDI-DI: 54040326MEDIADENTT5
Reference: Medische Hulpmiddelen (10005844)
EMDN: Z11079082
EMDN description: VARIOUS X-RAY FILM IMAGING SUPPORT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:45

Manufacturer products View details

SurgiCase Knee Planner

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Materialise NV
Manufacturer SRN: BE-MF-000000034
UDI-DI: 05404028001257
Basic UDI-DI: 54040280B1022VG
Reference: SurgiCase Knee Planner
EMDN: Z119092
EMDN description: VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:45

Manufacturer products View details

05214003139017

1.2.12

Class IIaMDR 2017/745On the marketNo EU repActive deviceDirect markingMeasuring function

Manufacturer: ΒΑΡΩΝΟΣ ΑΓΑΜ. ΚΑΙ ΣΙΑ Ο.Ε. με διακριτικό τίτλο KeV Medical Imaging
Manufacturer SRN: EL-MF-000044601
UDI-DI: 05214003139017
Basic UDI-DI: 5214003139QD01KJ
Reference: NA
EMDN: Z11029092
EMDN description: VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 09:47

Manufacturer products View details

iPACS

Class IMDR 2017/745On the marketNo EU repActive deviceDirect marking

Manufacturer: HEALTHCARE EXPERIENCE ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΟΛΟΚΛΗΡΩΜΕΝΩΝ ΛΥΣΕΩΝ ΙΑΤΡΙΚΗΣ ΠΛΗΡΟΦΟΡΙΚΗΣ ΙΑΤΡΙΚΟΥ ΕΞΟΠΛΙΜΟΥ-ΛΟΓΙΣΜΙΚΟΥ ΚΑΙ ΥΠΗΡΕΣΙΩΝ
Manufacturer SRN: EL-MF-000049418
UDI-DI: 05214002346010
Basic UDI-DI: 52140023463501AU
Reference: HC.003501
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:47

Manufacturer products View details

SOFT CARE

ULTRASOUND SERIES

Class IMDR 2017/745On the marketSingle use

Manufacturer: BOURNAS MEDICALS
Manufacturer SRN: GR-MF-000023099
UDI-DI: 05208107000281
Basic UDI-DI: 5208107104000QP
Reference: 104.006.IS
EMDN: Z11040185
EMDN description: ULTRASOUND SCANNERS - CONSUMABLES
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:43

Manufacturer products View details

ALFASHIELD - GEL ΥΠΕΡΗΧΟΥ 5000g

ULTRASOUND GEL

Class IMDR 2017/745On the market

Manufacturer: ΚΑΡΑΜΠΙΝΗΣ MEDICAL A.E.
Manufacturer SRN: GR-MF-000023526
UDI-DI: 05206355032818
Basic UDI-DI: 5206355USGL3T
Reference: GEL-AS-002
EMDN: Z11040185
EMDN description: ULTRASOUND SCANNERS - CONSUMABLES
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:42

Manufacturer products View details

SOFT CARE

ULTRASOUND SERIES

Class IMDR 2017/745On the marketSingle use

Manufacturer: BOURNAS MEDICALS
Manufacturer SRN: GR-MF-000023099
UDI-DI: 05208107000274
Basic UDI-DI: 5208107104000QP
Reference: 104.002.IS
EMDN: Z11040185
EMDN description: ULTRASOUND SCANNERS - CONSUMABLES
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:40

Manufacturer products View details

ALFASHIELD - GEL ΥΠΕΡΗΧΟΥ 260gr

ULTRASOUND GEL

Class IMDR 2017/745On the market

Manufacturer: ΚΑΡΑΜΠΙΝΗΣ MEDICAL A.E.
Manufacturer SRN: GR-MF-000023526
UDI-DI: 05206355032795
Basic UDI-DI: 5206355USGL3T
Reference: GEL-AS-001
EMDN: Z11040185
EMDN description: ULTRASOUND SCANNERS - CONSUMABLES
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:39

Manufacturer products View details

Eyonix

Eyonix R2

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Softjump Ltd
Manufacturer SRN: UK-MF-000052239
UDI-DI: 05070004468903
Basic UDI-DI: 50700044689EYR2BP3
Reference: EYR2B
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 31.07.2026 09:21

Manufacturer products Authorised representative products Authorised representative actors View details

Interventional Radiology

INV 02

Class IIaMDR 2017/745On the marketSterile

Manufacturer: SYNDEO Medical
Manufacturer SRN: BE-PR-000044136
UDI-DI: 05065021834114
Basic UDI-DI: 5065021834SYNPP011Z4
Reference: SYN-INV02-001
EMDN: Z11030599
EMDN description: RADIOLOGY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 09:17

Manufacturer products View details

DOSEmapper Beads

DOSEmapper Micro-Silica Bead TLDs

Class IMDR 2017/745On the market

Manufacturer: TRUEinvivo Limited
Manufacturer SRN: UK-MF-000036202
UDI-DI: 05065010948006
Basic UDI-DI: 5065010948DM-Beads-8D
Reference: DM0L
EMDN: Z119002
EMDN description: DOSIMETERS
First on market country: Ireland
Authorised representative: Advena Limited
Last updated: 31.07.2026 09:15

Manufacturer products Authorised representative products Authorised representative actors View details

Adaptix Ortho350

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Adaptix Limited
Manufacturer SRN: UK-MF-000048298
UDI-DI: 05061068070003
Basic UDI-DI: 506106807AD01-0850JE
Reference: AD01-0850
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: Ireland
Authorised representative: Advena Limited
Last updated: 31.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

ScanNav Anatomy: Peripheral Nerve Block

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Intelligent Ultrasound Limited
Manufacturer SRN: GB-MF-000002764
UDI-DI: 05060878810090
Basic UDI-DI: 506087881IU00187
Reference: v4.0
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:56

Manufacturer products Authorised representative products Authorised representative actors View details

05060757520003

3Dnet

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: BIOTRONICS 3D LIMITED
Manufacturer SRN: UK-MF-000051724
UDI-DI: 05060757520003
Basic UDI-DI: 506075752MEDICALIMAGINGLF
Reference: 506075752MEDICALIMAGINGLF
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Romania
Authorised representative: Skyer Medical Imaging S.R.L.
Last updated: 31.07.2026 08:53

Manufacturer products Authorised representative products Authorised representative actors View details

Low Contrast Test Tool

200

Class IMDR 2017/745On the market

Manufacturer: Sun Nuclear Corporation
Manufacturer SRN: US-MF-000021541
UDI-DI: 05060608881291
Basic UDI-DI: 506060888200PHQX
Reference: 200
EMDN: Z11030599
EMDN description: RADIOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sun Nuclear GmbH
Last updated: 31.07.2026 08:52

Manufacturer products Authorised representative products Authorised representative actors View details

SONICAID

ACC-OBS-008

Class IMDR 2017/745On the market

Manufacturer: ArjoHuntleigh AB
Manufacturer SRN: SE-MF-000000696
UDI-DI: 05051968008237
Basic UDI-DI: 5060693520440W7
Reference: 8400-6919
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 08:50

Manufacturer products View details

05060570830266

Blackford Accept Reject Tool

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Blackford Analysis Limited
Manufacturer SRN: UK-MF-000044937
UDI-DI: 05060570830266
Basic UDI-DI: 50605VIEWERSMK
Reference: BART001
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Norway
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

311/W Table Shield Wall Rack For 311/DS-020

Storage Racks for the radiation shields

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Kenex (Electro-Medical) Limited
Manufacturer SRN: GB-MF-000009022
UDI-DI: 05055449406604
Basic UDI-DI: 50554494AR9X
Reference: 311/W
EMDN: Z11030503
EMDN description: PATIENT TABLES FOR RADIOLOGICAL EQUIPMENT
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 08:16

Manufacturer products Authorised representative products Authorised representative actors View details