Public EUDAMED Search

EUDAMED Device Search

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

Last updated

21.09.2026 18:16

Sync status

Successful

Device

3135589

Actor

47649

Certificate

3295

Active filter:Authorised representative SRN:DE-AR-000028648

4 device results listed.

Page 1 / 1

BeVigilant™ Reader

BeVigilant™ Reader

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Vigilant Biosciences, Inc.
Manufacturer SRN
US-MF-000013534
UDI-DI
00860000930987
Basic UDI-DI
086000093099000011UM
Reference
9000011
EMDN
W0201020201
EMDN description
IMMUNOCHEMISTRY READERS
First on market country
Italy
Authorised representative
Vigilant Biosciences GmbH
Last updated
16.07.2026 06:50
BeVigilant™ Reader

BeVigilant™ Reader

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Vigilant Biosciences, Inc.
Manufacturer SRN
US-MF-000013534
UDI-DI
00860000930963
Basic UDI-DI
086000093099000002UL
Reference
9000002
EMDN
W0201020201
EMDN description
IMMUNOCHEMISTRY READERS
First on market country
Italy
Authorised representative
Vigilant Biosciences GmbH
Last updated
16.07.2026 06:50
OraFusion Software

OraFusion Software

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testing
Manufacturer
Vigilant Biosciences, Inc.
Manufacturer SRN
US-MF-000013534
UDI-DI
00850050841005
Basic UDI-DI
086000093094000005S5
Reference
4000005
EMDN
W0201069082
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country
Italy
Authorised representative
Vigilant Biosciences GmbH
Last updated
16.07.2026 06:48
Ora-3D

Ora-3D

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use
Manufacturer
Vigilant Biosciences, Inc.
Manufacturer SRN
US-MF-000013534
UDI-DI
00860000930949
Basic UDI-DI
B-00860000930949
Reference
9000006
EMDN
W0102160299
EMDN description
TUMOUR MARKER RT & POC - OTHER
First on market country
Italy
Authorised representative
Vigilant Biosciences GmbH
Last updated
05.07.2026 11:44