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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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03.08.2026 22:01

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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

05070003075607

hepatoSIGHT

Class IMDR 2017/745On the market

Manufacturer: Predictive Health Intelligence Ltd
Manufacturer SRN: UK-MF-000043900
UDI-DI: 05070003075607
Basic UDI-DI: 507000307hepatoSIGHTSR
Reference: N/A
EMDN: Z12040282
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 31.07.2026 09:20

Manufacturer products Authorised representative products Authorised representative actors View details

05070003024209

DName-iT

Class IMDR 2017/745On the market

Manufacturer: DName-iT Holdings Ltd
Manufacturer SRN: UK-MF-000044536
UDI-DI: 05070003024209
Basic UDI-DI: 507000302DName-iTV8
Reference: N/A
EMDN: Z12040282
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 31.07.2026 09:20

Manufacturer products Authorised representative products Authorised representative actors View details

MINDSTEP

Class IMDR 2017/745On the marketSingle use

Manufacturer: Mindset Technologies Ltd
Manufacturer SRN: UK-MF-000042217
UDI-DI: 05070002758303
Basic UDI-DI: 50700027583AA01AN
Reference: MINDSTEP
EMDN: Z12040282
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 31.07.2026 09:20

Manufacturer products Authorised representative products Authorised representative actors View details

05065020725000

Metadvice AI

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking

Manufacturer: Metadvice (Suisse) SA
Manufacturer SRN: CH-MF-000049909
UDI-DI: 05065020725000
Basic UDI-DI: 5065020725001RM
Reference: 001
EMDN: Z120499
EMDN description: GENERAL MEDICINE INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 31.07.2026 09:16

Manufacturer products Authorised representative products Authorised representative actors View details

05065010474000

FRAX

Class IMDR 2017/745On the market

Manufacturer: Osteoporosis Research Ltd
Manufacturer SRN: GB-MF-000025251
UDI-DI: 05065010474000
Basic UDI-DI: 506501047400FRAXBX
Reference: N.A
EMDN: Z12040282
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 31.07.2026 09:15

Manufacturer products Authorised representative products Authorised representative actors View details

OTD Dermatoscope

BAL 2000

Class IMDR 2017/745On the marketActive device

Manufacturer: DeepX Health Limited
Manufacturer SRN: GB-MF-000011958
UDI-DI: 15060920310001
Basic UDI-DI: 506092031dermatoscopeQP
Reference: BAL 2000
EMDN: Z12040118
EMDN description: VIDEO DERMATOSCOPES
First on market country: Northern Ireland
Authorised representative: Medical Device Management Ltd
Last updated: 31.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors 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

SmartPDT-D

SmartPDT

Class IMDR 2017/745On the marketDirect marking

Manufacturer: siHealth Ltd.
Manufacturer SRN: GB-MF-000034129
UDI-DI: 05060861070005
Basic UDI-DI: 506086107SIHSDTCV
Reference: SmartPDT-D
EMDN: Z12040292
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT 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

SteriPlas Sensor Module

ARPP-SP-02

Class IMDR 2017/745On the marketSingle use

Manufacturer: Adtec Healthcare Limited
Manufacturer SRN: GB-MF-000002105
UDI-DI: 05060758510027
Basic UDI-DI: 506075851SSMKT
Reference: ARPP-SP-02
EMDN: Z12040285
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: MedEnvoy Global BV
Last updated: 31.07.2026 08:53

Manufacturer products Authorised representative products Authorised representative actors View details

05060758510010

ARPP-SP2-01

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Adtec Healthcare Limited
Manufacturer SRN: GB-MF-000002105
UDI-DI: 05060758510010
Basic UDI-DI: 506075851NTGPDR
Reference: ARPP-SP2-01
EMDN: Z12040299
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: MedEnvoy Global BV
Last updated: 31.07.2026 08:53

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

AD2 Wireless Adaptor

Data Acquisition Products

Class IMDR 2017/745On the marketActive device

Manufacturer: Biometrics Ltd
Manufacturer SRN: GB-MF-000002774
UDI-DI: 05060481690621
Basic UDI-DI: 506048169DataAcqProdAD
Reference: AD2 DataLITE Wireless Adaptor
EMDN: Z12040199
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:52

Manufacturer products Authorised representative products Authorised representative actors View details

DOPPLEX

DMX

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: ArjoHuntleigh AB
Manufacturer SRN: SE-MF-000000696
UDI-DI: 05051968016799
Basic UDI-DI: 5060693520365WJ
Reference: D900-P
EMDN: Z12040111
EMDN description: BLOOD FLOW METERS
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 08:51

Manufacturer products View details

NovoTHOR

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: THOR Photomedicine Ltd
Manufacturer SRN: UK-MF-000039048
UDI-DI: 05060494130503
Basic UDI-DI: 506049413NOVOTHOR8R
Reference: S2188
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: France
Authorised representative: THOR Photomedicine EU Limited
Last updated: 31.07.2026 08:47

Manufacturer products Authorised representative products Authorised representative actors View details

Control Unit

LX2.3

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: THOR Photomedicine Ltd
Manufacturer SRN: UK-MF-000039048
UDI-DI: 05060494130336
Basic UDI-DI: 506049413LX2SYSTEMJW
Reference: S1022
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: France
Authorised representative: THOR Photomedicine EU Limited
Last updated: 31.07.2026 08:47

Manufacturer products Authorised representative products Authorised representative actors View details

05060461080589

MY-138

Class IIaMDR 2017/745On the market

Manufacturer: Venture Health Ltd
Manufacturer SRN: UK-MF-000047587
UDI-DI: 05060461080589
Basic UDI-DI: 50604610825007G8
Reference: MY-138
EMDN: Z12040210
EMDN description: ULTRASONIC NEBULISERS
First on market country: France
Authorised representative: Global E-commerce Experts Europe BV
Last updated: 31.07.2026 08:47

Manufacturer products Authorised representative products Authorised representative actors View details