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239 device results listed.

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inHEART Models Explorer

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: inHEART
Manufacturer SRN: FR-MF-000006723
UDI-DI: 03770019599105
Basic UDI-DI: 3770019599Explorerv2P5
Reference: v3
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: -
Last updated: 22.09.2026 23:16

Manufacturer products View details

inHEART Portal

Class IMDR 2017/745On the marketActive device

Manufacturer: inHEART
Manufacturer SRN: FR-MF-000006723
UDI-DI: 03770019599129
Basic UDI-DI: 3770019599Portalv42J
Reference: v4
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: -
Last updated: 22.09.2026 23:16

Manufacturer products View details

syngo.plaza

MDD_05_IIa_FOR GmbH_syngo.plaza

Class IIaMDDOn the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869096506
Basic UDI-DI: B-04056869096506
Reference: 11293724
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 10:40

Manufacturer products View details

D-UNIVIEW38Y

UNIVIEW III

Class IIaMDDNo longer on the marketActive deviceMeasuring function

Manufacturer: ENOVACOM
Manufacturer SRN: FR-MF-000000686
UDI-DI: D-UNIVIEW38Y
Basic UDI-DI: B-UNIVIEW38Y
Reference: UNIVIEW III version 1
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 22.09.2026 02:22

Manufacturer products View details

06977207040037

iOrtho Platform

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shanghai EA Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000040940
UDI-DI: 06977207040037
Basic UDI-DI: 697720704SOFTWARE002V8
Reference: iOrtho Platform
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.09.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

06977207040020

iOrtho

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shanghai EA Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000040940
UDI-DI: 06977207040020
Basic UDI-DI: 697720704SOFTWARE001V6
Reference: iOrtho
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.09.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

Heuron IPD

H-PD-D05

Class IIaMDDOn the marketActive device

Manufacturer: Heuron Co., Ltd.
Manufacturer SRN: KR-MF-000008614
UDI-DI: 08800086200033
Basic UDI-DI: 88000862PD01LJ
Reference: H-PD-D05
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: KTR Europe GmbH
Last updated: 22.09.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

IB Lab SQUIRREL

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: IB Lab GmbH
Manufacturer SRN: AT-MF-000006554
UDI-DI: 09120105730938
Basic UDI-DI: 912010573IBLABSQUIRRELDP
Reference: V1.1
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: -
Last updated: 21.09.2026 22:31

Manufacturer products View details

IB Lab LAMA

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: IB Lab GmbH
Manufacturer SRN: AT-MF-000006554
UDI-DI: 09120105730921
Basic UDI-DI: 912010573IBLABLAMAPE
Reference: V3.0
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: -
Last updated: 21.09.2026 22:31

Manufacturer products View details

IB Lab HIPPO

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: IB Lab GmbH
Manufacturer SRN: AT-MF-000006554
UDI-DI: 09120105730884
Basic UDI-DI: 912010573IBLABHIPPODB
Reference: V2.0
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: -
Last updated: 21.09.2026 22:31

Manufacturer products View details

Origin Edge Software Image, 1.0

Origin Edge Software Image

Class IMDR 2017/745On the marketActive device

Manufacturer: Brainlab SE
Manufacturer SRN: DE-MF-000006183
UDI-DI: 04056481145422
Basic UDI-DI: 4056481OriginEdgeMQ
Reference: 04056481145422
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 11.08.2026 23:48

Manufacturer products View details

00853341006701

4.x

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Heartflow, Inc.
Manufacturer SRN: US-MF-000020729
UDI-DI: 00853341006701
Basic UDI-DI: 0853341006FFRCTSW
Reference: Heartflow Analysis v4.x
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: MDSS GmbH
Last updated: 11.08.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

Syngo Carbon Enterprise Access

MDR_DnA_IIb_SHS_AG_SAMD_EntAccess

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthineers AG
Manufacturer SRN: DE-MF-000038456
UDI-DI: 04068151090086
Basic UDI-DI: 0405686902474W2
Reference: 11926875
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 08.08.2026 02:14

Manufacturer products 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: 05.08.2026 04:28

Manufacturer products Authorised representative products Authorised representative actors View details

Briefcase-Triage

BriefCase-Triage

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Aidoc Medical Ltd.
Manufacturer SRN: IL-MF-000030988
UDI-DI: 07290018052440
Basic UDI-DI: 7290018052BC.TRGSU
Reference: BC.TRG
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

aiOS

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Aidoc Medical Ltd.
Manufacturer SRN: IL-MF-000030988
UDI-DI: 07290018052402
Basic UDI-DI: 729001805219AD
Reference: aiOS
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Briefcase-Quantification

BriefCase-Quantification

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Aidoc Medical Ltd.
Manufacturer SRN: IL-MF-000030988
UDI-DI: 07290018052280
Basic UDI-DI: 7290018052BC.QTFSH
Reference: BC-QTF
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Contrast&Care+

SMD002

Class IMDDOn the marketActive device

Manufacturer: MEDEX
Manufacturer SRN: FR-MF-000000414
UDI-DI: 03700550400677
Basic UDI-DI: B-03700550400677
Reference: SMD002
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: -
Last updated: 02.08.2026 16:38

Manufacturer products View details

SHLView Version 4.06

SHLView Version 4.x

Class IIbMDR 2017/745No longer on the marketActive deviceDirect markingMeasuring function

Manufacturer: SHL Solutions for Healthcare and Life-Sciences GmbH
Manufacturer SRN: AT-MF-000004566
UDI-DI: 09120122170014
Basic UDI-DI: 912012217SHLVIEW4SG
Reference: SHLVIEW4
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 01.08.2026 00:41

Manufacturer products View details

09120117253005

PIUR tUS inside

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: piur imaging GmbH
Manufacturer SRN: AT-MF-000001067
UDI-DI: 09120117253005
Basic UDI-DI: 9120117253005S6
Reference: 0202
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:40

Manufacturer products View details