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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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Coolite Evo

GP900A8

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shenzhen GSD Tech Co., Ltd.
Manufacturer SRN: CN-MF-000002168
UDI-DI: 06928258000426
Basic UDI-DI: 69282580GP900SERIES7Z
Reference: GP900Q6
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

Lumoral protective plastic cover

Class IMDR 2017/745On the marketSingle use

Manufacturer: Koite Health Oy
Manufacturer SRN: FI-MF-000006901
UDI-DI: 06429810197283
Basic UDI-DI: 6429810197Plasticcover7J
Reference: 60
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:38

Manufacturer products View details

Lumorinse

Class IIaMDR 2017/745On the market

Manufacturer: Koite Health Oy
Manufacturer SRN: FI-MF-000006901
UDI-DI: 06429810197207
Basic UDI-DI: 6429810197Lumorinsetabl4P
Reference: N/A
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:38

Manufacturer products View details

Lumoral Junior

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Koite Health Oy
Manufacturer SRN: FI-MF-000006901
UDI-DI: 06429810197191
Basic UDI-DI: 6429810197LumoralJunioB8
Reference: 21
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:38

Manufacturer products View details

Lumoral Clinic

03, 13

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Koite Health Oy
Manufacturer SRN: FI-MF-000006901
UDI-DI: 06429810197184
Basic UDI-DI: 6429810197LumoralClini66
Reference: 03, 13
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:38

Manufacturer products View details

Lumoral Treatment

01, 11

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Koite Health Oy
Manufacturer SRN: FI-MF-000006901
UDI-DI: 06429810197153
Basic UDI-DI: 6429810197LumoralTreatmP6
Reference: 01, 03
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:38

Manufacturer products View details

Lumoral Junior

Class IMDR 2017/745On the market

Manufacturer: Koite Health Oy
Manufacturer SRN: FI-MF-000006901
UDI-DI: 06429810197085
Basic UDI-DI: 6429810197LumoralJuniorP7
Reference: 21
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:38

Manufacturer products View details

Lumoral

10000mAh

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Koite Health Oy
Manufacturer SRN: FI-MF-000006901
UDI-DI: 06429810197030
Basic UDI-DI: 6429810197LumoralPowerbQ7
Reference: N/A
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:38

Manufacturer products View details

CVN Arctic Pallas Hypothermia Bag

H5000

Class IMDR 2017/745On the marketDirect marking

Manufacturer: CVN medical Oy
Manufacturer SRN: FI-MF-000032554
UDI-DI: 06429810144133
Basic UDI-DI: 6429810144H5000QW
Reference: H5000-5016P
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

Manufacturer products View details

Puregraft 50

50/Pure

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Bimini Health Tech
Manufacturer SRN: US-MF-000008649
UDI-DI: 00850034511122
Basic UDI-DI: 085003451150/PUREAA
Reference: 50/PURE
EMDN: Z12040214
EMDN description: LIPOSUCTION SYSTEMS
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 16:05

Manufacturer products Authorised representative products Authorised representative actors View details

MANUALEX PRO

MANUALEX

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Sanimed Jarosław Jędrzejowski
Manufacturer SRN: PL-MF-000051705
UDI-DI: 05906168035623
Basic UDI-DI: 59061680356MANUALEXC8
Reference: MANUALEX-PRO
EMDN: Z12040299
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:12

Manufacturer products View details

CarnaLife Holo

Class IIaMDR 2017/745On the marketMeasuring function

Manufacturer: MEDAPP SPÓŁKA AKCYJNA
Manufacturer SRN: PL-MF-000029453
UDI-DI: 05904978657028
Basic UDI-DI: 5904978657CLHJV
Reference: 05904978657028
EMDN: Z12040292
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:57

Manufacturer products View details

MENO! App

1.0

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Sidekick Health
Manufacturer SRN: IS-MF-000014435
UDI-DI: 05694312411101
Basic UDI-DI: 569431241MENO!D2
Reference: MENO! App
EMDN: Z12040292
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 11:56

Manufacturer products View details

ADVATx

1.4

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableDirect markingEMR

Manufacturer: Advalight
Manufacturer SRN: DK-MF-000010334
UDI-DI: 05700002052209
Basic UDI-DI: 57000020522A00B4
Reference: ADVATx
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 11:47

Manufacturer products View details

MENO! App

1.0

Class IMDR 2017/745No longer on the marketActive deviceDirect marking

Manufacturer: Sidekick Health
Manufacturer SRN: IS-MF-000014435
UDI-DI: 05694312411002
Basic UDI-DI: 569431241MENO!D2
Reference: MENO! App
EMDN: Z12040292
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 11:47

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

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

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