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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

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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

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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

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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

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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

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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

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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

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

OP-MV22 MD FULL HD

MONITOR

Class IMDR 2017/745On the market

Manufacturer: OPTOMIC ESPAÑA S.A
Manufacturer SRN: ES-MF-000003235
UDI-DI: 08436041580492
Basic UDI-DI: 84360415801202C
Reference: 10110264
EMDN: Z11039004
EMDN description: TELEVISION SYSTEMS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:49

Manufacturer products View details

CS31SL

Ceiling

Class IMDR 2017/745On the market

Manufacturer: General Medical Merate S.p.A.
Manufacturer SRN: IT-MF-000023169
UDI-DI: 08054890480901
Basic UDI-DI: 805489048PENQ7
Reference: CS31SL
EMDN: Z11030502
EMDN description: CEILING STANDS FOR RADIOLOGICAL EQUIPMENT
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 22:28

Manufacturer products View details

OEC One CFD

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00840682145541
Basic UDI-DI: 8406821BUG00297HX
Reference: 7999000PCM
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

OEC One ASD

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278685001
Basic UDI-DI: 8406821BUG00455HR
Reference: OEC One ASD
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

Head Auto Views

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278629586
Basic UDI-DI: 8406821BUG00411H5
Reference: 5929651
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac X-ray Analysis

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278623287
Basic UDI-DI: 8406821BUG00452HK
Reference: 5948564
EMDN: Z11030192
EMDN description: DIGITAL ANGIOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:27

Manufacturer products View details

Quality Care Suite 2.0

Quality Care Suite

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278584441
Basic UDI-DI: 8406821BUG00407HE
Reference: S3003CV, S3003EV
EMDN: Z11039092
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details