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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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Ensight

Class IMDR 2017/745On the market

Manufacturer: Enlitic, Inc.
Manufacturer SRN: US-MF-000022843
UDI-DI: 00860002304557
Basic UDI-DI: 008600023045EnsightX7
Reference: 10005
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 22:38

Manufacturer products Authorised representative products Authorised representative actors View details

Glooko XT

REF-0009

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Glooko, Inc.
Manufacturer SRN: US-MF-000023483
UDI-DI: 00855093008101
Basic UDI-DI: 0085509300REF-0009V8
Reference: REF-0009
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: France
Authorised representative: MedEnvoy Global BV
Last updated: 15.07.2026 22:37

Manufacturer products Authorised representative products Authorised representative actors View details

Glooko XT

REF-0010

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Glooko, Inc.
Manufacturer SRN: US-MF-000023483
UDI-DI: 00855093008095
Basic UDI-DI: 0085509300REF-0010UR
Reference: REF-0010
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: France
Authorised representative: MedEnvoy Global BV
Last updated: 15.07.2026 22:37

Manufacturer products Authorised representative products Authorised representative actors View details

Glooko Transmitter

REF-0003

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Glooko, Inc.
Manufacturer SRN: US-MF-000023483
UDI-DI: 00855093008057
Basic UDI-DI: 0085509300TransRef003SQ
Reference: REF-0003
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Sweden
Authorised representative: MedEnvoy Global BV
Last updated: 15.07.2026 22:37

Manufacturer products Authorised representative products Authorised representative actors View details

Glooko Mobile Application

REF-0002

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Glooko, Inc.
Manufacturer SRN: US-MF-000023483
UDI-DI: 00855093008033
Basic UDI-DI: 0085509300MobileRef0023N
Reference: REF-0002
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Sweden
Authorised representative: MedEnvoy Global BV
Last updated: 15.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Glooko Web Application

REF-0001

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Glooko, Inc.
Manufacturer SRN: US-MF-000023483
UDI-DI: 00855093008026
Basic UDI-DI: 0085509300WebAppRef001LF
Reference: REF-0001
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Sweden
Authorised representative: MedEnvoy Global BV
Last updated: 15.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Soarian Critical Care

Class IMDR 2017/745On the marketActive device

Manufacturer: Cerner Corporation
Manufacturer SRN: US-MF-000007215
UDI-DI: 00853023006517
Basic UDI-DI: 00853023006CERNSCCT8
Reference: 1000024
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Germany
Authorised representative: Oracle Nederland BV
Last updated: 15.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

00853023006500

Soarian Clinicals

Class IMDR 2017/745On the marketActive device

Manufacturer: Cerner Corporation
Manufacturer SRN: US-MF-000007215
UDI-DI: 00853023006500
Basic UDI-DI: 00853023006CERNSCHU
Reference: 07591964 07590248 07590230 07603512 07590255
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Germany
Authorised representative: Oracle Nederland BV
Last updated: 15.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Invisalign Virtual Care

Virtual Care

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Align Technology Inc.
Manufacturer SRN: US-MF-000000744
UDI-DI: 00816063023319
Basic UDI-DI: 0081606302A040648VC68
Reference: A040648
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 15.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

FOEDORA

Class IMDR 2017/745On the market

Manufacturer: FOEDORA
Manufacturer SRN: FR-MF-000039740
UDI-DI: 03770038212009
Basic UDI-DI: 0038212F01012025ZK
Reference: FD001
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 22:10

Manufacturer products View details

tiphyHealth

4260748790021

Class IMDR 2017/745On the marketDirect marking

Manufacturer: henworx GmbH & Co. KG
Manufacturer SRN: DE-MF-000009440
UDI-DI: 42607487900210
Basic UDI-DI: 0000000426074879AA
Reference: 002
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 21:59

Manufacturer products View details

QuestManager

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Lighthouse software B.V.
Manufacturer SRN: NL-MF-000039130
UDI-DI: 00111963620232
Basic UDI-DI: 001119QuestManager96
Reference: 6.3.6
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Netherlands
Authorised representative: -
Last updated: 15.07.2026 21:58

Manufacturer products View details

Syntphony Digital Health Builder

SYNTDHBUILDER1

Class IMDR 2017/745On the marketActive device

Manufacturer: NTT DATA Italia S.p.A.
Manufacturer SRN: IT-MF-000047521
UDI-DI: G759SYNTDHBUILDER10
Basic UDI-DI: ++G759SYNTDHBUILDERTF
Reference: SYNTDHBUILDER1
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 21:35

Manufacturer products View details

PRAID AI Personal Assistant Tool

BPAI-T004

Class IMDR 2017/745On the market

Manufacturer: BAYANAAT NAHW AL MUSTAQBAL (PRIVATE) LIMITED
Manufacturer SRN: PK-MF-000052649
UDI-DI: +G841BPAIT0041$
Basic UDI-DI: ++G841PRAIDAIPERSONALASPF
Reference: BPAI-T004
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

PRAID AI Annotation Tool

BPAI-T001

Class IMDR 2017/745On the marketActive device

Manufacturer: BAYANAAT NAHW AL MUSTAQBAL (PRIVATE) LIMITED
Manufacturer SRN: PK-MF-000052649
UDI-DI: +G841BPAIT0011-
Basic UDI-DI: ++G841PRAIDAIANNOTATIONE3
Reference: BPAI-T001
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

++G838YOUWELLPLATFORMUJD2

Platform-01

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Youwell AS
Manufacturer SRN: NO-MF-000049344
UDI-DI: ++G838YOUWELLPLATFORMUJD2
Basic UDI-DI: ++G838YOUWELLPLATFORMUJ
Reference: 01
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Norway
Authorised representative: -
Last updated: 15.07.2026 21:30

Manufacturer products View details

Breathment

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Breathment GmbH
Manufacturer SRN: DE-MF-000036840
UDI-DI: G558BCOPD10
Basic UDI-DI: ++G558G558BCOPD10ZE
Reference: BCOPD1
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 21:27

Manufacturer products View details

Hybrid Microscope Software

Hybrid Microscope

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: X-ZELL Biotech Pte. Ltd.
Manufacturer SRN: SG-MF-000039227
UDI-DI: ++G580XZELLHybrScopeAFS1
Basic UDI-DI: ++G580XZELLHybrScopeAFS
Reference: XZ1027
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Germany
Authorised representative: X-ZELL Biotech GmbH
Last updated: 15.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

Calculators & Scales

1.16.0

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: TONIC EASY MEDICAL, S.A.
Manufacturer SRN: PT-MF-000035218
UDI-DI: G49011600Z
Basic UDI-DI: ++G49011602A
Reference: 1160
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Portugal
Authorised representative: -
Last updated: 15.07.2026 21:11

Manufacturer products View details

Tonic Drugs

1.2.1

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: TONIC EASY MEDICAL, S.A.
Manufacturer SRN: PT-MF-000035218
UDI-DI: +G4901210V
Basic UDI-DI: ++G490121LZ
Reference: 1.2.1
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Portugal
Authorised representative: -
Last updated: 15.07.2026 21:10

Manufacturer products View details