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31.07.2026 19:58

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Active filter:EMDN:Z12040192

232 device results listed.

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iCan Review

V01

Class IMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175023387
Basic UDI-DI: 6934175005A0004PT
Reference: N/A
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare iCan

Android: V01; iOS: V01

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175001323
Basic UDI-DI: 6934175005A0002PP
Reference: N/A
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

Bittium MedicalSuite Center

MedicalSuite Center v3.x

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035221028
Basic UDI-DI: 643003522SuiteCYA
Reference: S0000022661
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

Manufacturer products View details

TwinSkin

2.1.8.1

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Dermatoo SRL
Manufacturer SRN: BE-MF-000038919
UDI-DI: 05419980652607
Basic UDI-DI: 54199806526TS.App.v1MG
Reference: version 1
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:55

Manufacturer products View details

Healthentia v4

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: INNOVATION SPRINT SRL
Manufacturer SRN: BE-MF-000000879
UDI-DI: 05419980178930
Basic UDI-DI: 54199801789HLTv4GY
Reference: Healthentia v4
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:54

Manufacturer products View details

KroniKare

KKSCAN2

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: KroniKare Pte Ltd
Manufacturer SRN: SG-MF-000012230
UDI-DI: 05060890010089
Basic UDI-DI: 506089001KKSCAN2DQ
Reference: KKSCAN2
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 08:56

Manufacturer products Authorised representative products Authorised representative actors View details

KroniKare

KroniKare iThermo Thermal Scanner

Class IIaMDR 2017/745On the marketMeasuring function

Manufacturer: KroniKare Pte Ltd
Manufacturer SRN: SG-MF-000012230
UDI-DI: 05060890010034
Basic UDI-DI: 5060890010ITS3W
Reference: iTSCAN1
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 08:56

Manufacturer products Authorised representative products Authorised representative actors View details

KroniKare

WS21

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: KroniKare Pte Ltd
Manufacturer SRN: SG-MF-000012230
UDI-DI: 05060890010003
Basic UDI-DI: 5060890010KWS4H
Reference: KKSCAN1
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 08:56

Manufacturer products Authorised representative products Authorised representative actors View details

Sun4Health App iOS

Sun4Health

Class IMDR 2017/745On the marketDirect marking

Manufacturer: siHealth Ltd.
Manufacturer SRN: GB-MF-000034129
UDI-DI: 05060861070104
Basic UDI-DI: 506086107SIHS4HAQ
Reference: Sun4Health App iOS
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Northern Ireland
Authorised representative: siHealth Photonics S.r.l.
Last updated: 31.07.2026 08:56

Manufacturer products Authorised representative products Authorised representative actors View details

DERM

Deep Ensemble for Recognition of Malignancy (DERM) V4

Class IIIMDR 2017/745No longer on the marketActive device

Manufacturer: Skin Analytics Ltd.
Manufacturer SRN: GB-MF-000017972
UDI-DI: 05060717730060
Basic UDI-DI: 506071773DERM-DX-CEMDRXU
Reference: DERM v4.1
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Lithuania
Safety summary (SSCP/SSP): SA-004747-RG · Rev. 5
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:52

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Feetsee

SW v1.1

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: UAB DIABETIS
Manufacturer SRN: LT-MF-000041929
UDI-DI: 04779060790102
Basic UDI-DI: 477906079FE.-1.A6E
Reference: REF_TEST
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Lithuania
Authorised representative: -
Last updated: 31.07.2026 07:08

Manufacturer products View details

MiiS

SA 1

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Medimaging Integrated Solution Inc
Manufacturer SRN: TW-MF-000009317
UDI-DI: 04719872717034
Basic UDI-DI: 471987271700095
Reference: Model: SA 1
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

04260744820548

Ada Assess

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Ada Health GmbH
Manufacturer SRN: DE-MF-000009202
UDI-DI: 04260744820548
Basic UDI-DI: 426074482AdaAssessPW
Reference: not applicable
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 05:29

Manufacturer products View details

SYMC

Class IIaMDR 2017/745On the marketActive device

Manufacturer: DOCYET GmbH
Manufacturer SRN: DE-MF-000007275
UDI-DI: 04262382550009
Basic UDI-DI: 426238255SYMCFB
Reference: 04262382550009
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:23

Manufacturer products View details

04260744820531

Ada Assess

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Ada Health GmbH
Manufacturer SRN: DE-MF-000009202
UDI-DI: 04260744820531
Basic UDI-DI: 426074482AdaAssessPW
Reference: not applicable
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:22

Manufacturer products View details

Clinic WinData

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NEXUS / E&L GmbH
Manufacturer SRN: DE-MF-000006906
UDI-DI: 04260721060073
Basic UDI-DI: 426072106CWDIIa5T
Reference: 09.14.xx
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:22

Manufacturer products View details

04260744820524

Ada Assess

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Ada Health GmbH
Manufacturer SRN: DE-MF-000009202
UDI-DI: 04260744820524
Basic UDI-DI: 426074482AdaAssessPW
Reference: not applicable
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:14

Manufacturer products View details

Clinic WinData

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NEXUS / E&L GmbH
Manufacturer SRN: DE-MF-000006906
UDI-DI: 04260721060066
Basic UDI-DI: 426072106CWDIIa5T
Reference: 09.13.xx
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:14

Manufacturer products View details

NEXUS / Scoring

Class IIaMDR 2017/745On the marketActive device

Manufacturer: NEXUS / CMC GmbH
Manufacturer SRN: DE-MF-000007980
UDI-DI: 04260686517056
Basic UDI-DI: 426068651700BM
Reference: 26.2
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:13

Manufacturer products View details

04260158450430

2026.1

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: FotoFinder Systems GmbH
Manufacturer SRN: DE-MF-000007084
UDI-DI: 04260158450430
Basic UDI-DI: 426015845HUB001ZS
Reference: N/a
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:38

Manufacturer products View details