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ICH Bleeding Detection

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Cercare Medical A/S
Manufacturer SRN: DK-MF-000002148
UDI-DI: 05745000308187
Basic UDI-DI: 5745000308CMNICHYA
Reference: ICH Bleeding Detection ver. 15
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:39

Manufacturer products View details

Virtual Expert

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Cercare Medical A/S
Manufacturer SRN: DK-MF-000002148
UDI-DI: 05745000308170
Basic UDI-DI: 5745000308CMNVIRTUALEXEH
Reference: Virtual Expert ver. 15
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:39

Manufacturer products View details

RBfracture

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Radiobotics ApS
Manufacturer SRN: DK-MF-000023156
UDI-DI: 05700002173676
Basic UDI-DI: 57000021736RB02BJ
Reference: RBfracture
EMDN: Z11030582
EMDN description: RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 11:56

Manufacturer products View details

05700002173645

RBknee

Class IIaMDR 2017/745No longer on the marketDirect markingMeasuring function

Manufacturer: Radiobotics ApS
Manufacturer SRN: DK-MF-000023156
UDI-DI: 05700002173645
Basic UDI-DI: 57000021736RB01BG
Reference: 4
EMDN: Z11030582
EMDN description: RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 11:48

Manufacturer products View details

05700002173638

RBfracture

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Radiobotics ApS
Manufacturer SRN: DK-MF-000023156
UDI-DI: 05700002173638
Basic UDI-DI: 57000021736RB02BJ
Reference: 3
EMDN: Z11030582
EMDN description: RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 11:48

Manufacturer products View details

WS-Manual-T-001

DR Wallstand 5520

Class IMDR 2017/745On the marketActive device

Manufacturer: Agfa NV
Manufacturer SRN: BE-MF-000000571
UDI-DI: 05414904176474
Basic UDI-DI: 5414904272596YV
Reference: 51F5R
EMDN: Z11030501
EMDN description: COLUMN STANDS FOR RADIOLOGICAL EQUIPMENT
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:00

Manufacturer products View details

WS-Manual-001

DR Wallstand 5520

Class IMDR 2017/745On the marketActive device

Manufacturer: Agfa NV
Manufacturer SRN: BE-MF-000000571
UDI-DI: 05414904176467
Basic UDI-DI: 5414904272596YV
Reference: 51F4P
EMDN: Z11030501
EMDN description: COLUMN STANDS FOR RADIOLOGICAL EQUIPMENT
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:53

Manufacturer products View details

DX-D FLFS Stand

DR FLFS accessory

Class IMDR 2017/745On the marketActive device

Manufacturer: Agfa NV
Manufacturer SRN: BE-MF-000000571
UDI-DI: 05414904098127
Basic UDI-DI: 5414904272657YQ
Reference: 5SN1F
EMDN: Z11030501
EMDN description: COLUMN STANDS FOR RADIOLOGICAL EQUIPMENT
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:52

Manufacturer products 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

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

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

1330/4/1 Mobile Detector Holder

X-ray film cassette holder

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Kenex (Electro-Medical) Limited
Manufacturer SRN: GB-MF-000009022
UDI-DI: 05055449402958
Basic UDI-DI: 50554494CH9H
Reference: 1330/4/1
EMDN: Z11030501
EMDN description: COLUMN STANDS 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

312/DS/3.128 57x24cm High Lift Off Top Shield

Table mounted radiation shields

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Kenex (Electro-Medical) Limited
Manufacturer SRN: GB-MF-000009022
UDI-DI: 05055449402385
Basic UDI-DI: 50554494SHTXZ
Reference: 312/DS/3.128
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

CT Eye

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Oxipit, UAB
Manufacturer SRN: LT-MF-000022304
UDI-DI: 04779050430131
Basic UDI-DI: 477905043CTEYEGQ
Reference: 1
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Lithuania
Authorised representative: -
Last updated: 31.07.2026 07:04

Manufacturer products View details

MSK Eye

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Oxipit, UAB
Manufacturer SRN: LT-MF-000022304
UDI-DI: 04779050430124
Basic UDI-DI: 477905043MSKEYEPV
Reference: 1
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Lithuania
Authorised representative: -
Last updated: 31.07.2026 07:04

Manufacturer products View details

04719893520019

RS010100

Class IMDR 2017/745On the market

Manufacturer: RADIRAD CO., LTD.
Manufacturer SRN: TW-MF-000033086
UDI-DI: 04719893520019
Basic UDI-DI: 471989352RS010100RR
Reference: RS010100
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Luana Med. B.V.
Last updated: 31.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

Mobile X-ray System Mobirex i9

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Shimadzu Corporation
Manufacturer SRN: JP-MF-000025145
UDI-DI: 04540217072729
Basic UDI-DI: 45402170100000000000014SV
Reference: 566-20000-76
EMDN: Z11030599
EMDN description: RADIOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shimadzu Europa GmbH
Last updated: 31.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

Mobile X-ray System FDR Go

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Shimadzu Corporation
Manufacturer SRN: JP-MF-000025145
UDI-DI: 04540217072699
Basic UDI-DI: 45402170100000000000013ST
Reference: 566-20000-66
EMDN: Z11030599
EMDN description: RADIOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shimadzu Europa GmbH
Last updated: 31.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

FDR Visionary Suite

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Shimadzu Corporation
Manufacturer SRN: JP-MF-000025145
UDI-DI: 04540217071586
Basic UDI-DI: 45402170100000000000012SR
Reference: 566-16130-80
EMDN: Z11030599
EMDN description: RADIOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shimadzu Europa GmbH
Last updated: 31.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

RADspeed Pro

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Shimadzu Corporation
Manufacturer SRN: JP-MF-000025145
UDI-DI: 04540217071319
Basic UDI-DI: 45402170100000000000003SQ
Reference: 566-26000-50
EMDN: Z11030599
EMDN description: RADIOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shimadzu Europa GmbH
Last updated: 31.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details