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Trauma DR plus

Class IIbMDR 2017/745On the market

Manufacturer: Oldelft Benelux B.V.
Manufacturer SRN: NL-PR-000013761
UDI-DI: 18720256816413
Basic UDI-DI: 8720256816Trauma_DR+97
Reference: BUCxxxx
EMDN: Z11039012
EMDN description: X-RAY TUBE ASSEMBLY
First on market country: -
Authorised representative: -
Last updated: 01.08.2026 00:04

Manufacturer products View details

VXvue

Class IIaMDR 2017/745On the market

Manufacturer: Vieworks Co., Ltd.
Manufacturer SRN: KR-MF-000020017
UDI-DI: 08809394330371
Basic UDI-DI: 880939433VXvue8X
Reference: VXvue
EMDN: Z11031182
EMDN description: SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: Vieworks EU GmbH
Last updated: 01.08.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

VIVIX-S 2530VW

VIVIX-S VW Series, VIVIX-S FW Series

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Vieworks Co., Ltd.
Manufacturer SRN: KR-MF-000020017
UDI-DI: 08809394330296
Basic UDI-DI: 880939433VIVIXSVW2H
Reference: FXRD-2530VAW
EMDN: Z11031180
EMDN description: SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Vieworks EU GmbH
Last updated: 01.08.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

VIVIX-S 1717V

VIVIX-S 1717V, VIVIX-S 1751S, VIVIX-S 4386W

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Vieworks Co., Ltd.
Manufacturer SRN: KR-MF-000020017
UDI-DI: 08809394330241
Basic UDI-DI: 880939433VIVIXS1717V2Y
Reference: FXRD-1717VA
EMDN: Z11031180
EMDN description: SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Vieworks EU GmbH
Last updated: 01.08.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

BT-DA12M, Pinkview-UPS

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: BONTECH Co., Ltd.
Manufacturer SRN: KR-MF-000048185
UDI-DI: 08800069500075
Basic UDI-DI: 880006950CG0812VG
Reference: BT-DMF-008
EMDN: Z11030599
EMDN description: RADIOLOGY INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 31.07.2026 23:58

Manufacturer products Authorised representative products Authorised representative actors View details

BT-DA22-IA

BT-DA24-IA, BT-DB24-IA, BT-DA22-IA, BT-DB22-IA, BT-DA22W, BT-DB22W

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: BONTECH Co., Ltd.
Manufacturer SRN: KR-MF-000048185
UDI-DI: 08800069500013
Basic UDI-DI: 880006950CG2422WWV
Reference: BT-DMF-003
EMDN: Z11030599
EMDN description: RADIOLOGY INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 31.07.2026 23:58

Manufacturer products Authorised representative products Authorised representative actors View details

REMEX-KA6

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: REMEDI Inc.
Manufacturer SRN: KR-MF-000026327
UDI-DI: 08800060100151
Basic UDI-DI: 88000601REMEX-WBS6
Reference: REM-IFU-KA6
EMDN: Z11039016
EMDN description: MOBILE RADIOGRAPHIC UNITS
First on market country: Italy
Authorised representative: JaviTech e.K.
Last updated: 31.07.2026 23:58

Manufacturer products Authorised representative products Authorised representative actors View details

AVIEW

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Coreline Soft Co., Ltd.
Manufacturer SRN: KR-MF-000011555
UDI-DI: 08800025300114
Basic UDI-DI: 88000253A001B2
Reference: CLS-USR-003(EU)
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: JaviTech e.K.
Last updated: 31.07.2026 23:58

Manufacturer products Authorised representative products Authorised representative actors View details

AIDIA Nex

Digital Mammography System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: DRTECH Corporation
Manufacturer SRN: KR-MF-000012441
UDI-DI: 08800018423103
Basic UDI-DI: 88000184SMXXXXXXXXBV
Reference: RMF-2000B
EMDN: Z11030202
EMDN description: DIGITAL MAMMOGRAPHY SYSTEMS
First on market country: Germany
Authorised representative: DRTECH Europe GmbH
Last updated: 31.07.2026 23:57

Manufacturer products Authorised representative products Authorised representative actors View details

Class IIbMDR 2017/745On the marketActive device

Manufacturer: OSSTEM IMPLANT CO.,LTD
Manufacturer SRN: KR-MF-000021655
UDI-DI: 08800000995809
Basic UDI-DI: 8800406N1SC
Reference: N1
EMDN: Z1103040102
EMDN description: EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 23:57

Manufacturer products Authorised representative products Authorised representative actors View details

08800000995601

Class IIbMDR 2017/745On the marketActive device

Manufacturer: OSSTEM IMPLANT CO.,LTD
Manufacturer SRN: KR-MF-000021655
UDI-DI: 08800000995601
Basic UDI-DI: 8800406T2SY
Reference: T2-C
EMDN: Z11030607
EMDN description: COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 23:57

Manufacturer products Authorised representative products Authorised representative actors View details

StrokeSENS

v2.x

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Circle Cardiovascular Imaging Inc
Manufacturer SRN: CA-MF-000011835
UDI-DI: 00882916001025
Basic UDI-DI: 882916SSX6N
Reference: v2.x
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Spain
Authorised representative: QDossier B.V.
Last updated: 31.07.2026 23:57

Manufacturer products Authorised representative products Authorised representative actors View details

TruPlan

v3.x

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Circle Cardiovascular Imaging Inc
Manufacturer SRN: CA-MF-000011835
UDI-DI: 00882916000523
Basic UDI-DI: 882916TRP68
Reference: TruPlan v2.1
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Spain
Authorised representative: QDossier B.V.
Last updated: 31.07.2026 23:57

Manufacturer products Authorised representative products Authorised representative actors View details

LLS-1-410

Class INot specifiedOn the marketDirect marking

Manufacturer: Oldelft Benelux B.V.
Manufacturer SRN: NL-MF-000005892
UDI-DI: 18720256816215
Basic UDI-DI: 8720256816LLS-16C
Reference: LLS-1-yyyy-xxxx
EMDN: Z11079007
EMDN description: CASSETTES FOR X–RAY FILMS
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:54

Manufacturer products View details

Easy DR

Easy DR Plus

Class IMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Oldelft Benelux B.V.
Manufacturer SRN: NL-MF-000005892
UDI-DI: 18720256816048
Basic UDI-DI: 8720256816Easy_DRNQ
Reference: 044H07200
EMDN: Z11039012
EMDN description: X-RAY TUBE ASSEMBLY
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:54

Manufacturer products View details

Stand Easy DR (145 version, rotation)

Easy DR Stand

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Oldelft Benelux B.V.
Manufacturer SRN: NL-MF-000005892
UDI-DI: 18720256816024
Basic UDI-DI: 8720256816EasyDRstand9J
Reference: 044I00607
EMDN: Z11079080
EMDN description: VARIOUS SUPPORTING INSTRUMENTS FOR X-RAY FILM SYSTEM - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:54

Manufacturer products View details

Varex Imaging

SolidStateMC series

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Varex Imaging Group Nederland B.V.
Manufacturer SRN: NL-MF-000002153
UDI-DI: 08718755004090
Basic UDI-DI: 8718755004DN
Reference: 176526
EMDN: Z11030599
EMDN description: RADIOLOGY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 23:47

Manufacturer products View details

Varex Imaging

Ionchamber series

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Varex Imaging Group Nederland B.V.
Manufacturer SRN: NL-MF-000002153
UDI-DI: 08718755003444
Basic UDI-DI: 8718755006DS
Reference: 168357
EMDN: Z11030599
EMDN description: RADIOLOGY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 23:47

Manufacturer products View details

XERA

XEBS-W1-LF

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: XERA Medical Systems and Technology Ltd.
Manufacturer SRN: TR-MF-000022581
UDI-DI: 08683161912034
Basic UDI-DI: 8683161912XLF01DU
Reference: XEBS-W1-LF
EMDN: Z11031180
EMDN description: SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:27

Manufacturer products View details

NVFundus

NV FUNDUS

Class IMDR 2017/745On the marketActive device

Manufacturer: URAL TELEKOMÜNİKASYON SAN. TİC. A.Ş
Manufacturer SRN: TR-MF-000024209
UDI-DI: 08683079746707
Basic UDI-DI: 86830797467NVFundus5H
Reference: NVFundus
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:27

Manufacturer products View details