Veriler yükleniyor…

Public EUDAMED Search

EUDAMED Device Search

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

Last updated

01.08.2026 00:16

Sync status

Successful

Device

2988209

Actor

47516

Certificate

3174

Filters

Show filters

Active filter:EMDN:W0102100102

18 device results listed.

Page 1 / 1

ENA Profile

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: AIDA GmbH
Manufacturer SRN: DE-MF-000040784
UDI-DI: 04260158680035
Basic UDI-DI: B-04260158680035
Reference: 10103
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 25.07.2026 17:31

Manufacturer products View details

ENA Screen

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: AIDA GmbH
Manufacturer SRN: DE-MF-000040784
UDI-DI: 04260158680028
Basic UDI-DI: B-04260158680028
Reference: 10102
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 25.07.2026 17:31

Manufacturer products View details

AESKULISA® ENA-6 Stripes

AESKULISA® ENA-6 Stripes

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289503495
Basic UDI-DI: B-04250289503495
Reference: 3120
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 20.07.2026 18:38

Manufacturer products View details

AESKULISA® ENA-6Pro

AESKULISA® ENA-6Pro

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500456
Basic UDI-DI: B-04250289500456
Reference: 3103
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

AESKULISA® ENA-6S

AESKULISA® ENA-6S

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500449
Basic UDI-DI: B-04250289500449
Reference: 3102
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

ENA screen

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147192914
Basic UDI-DI: B-86060147192914
Reference: N703A24ENA
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:13

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash® ENA7 Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950627821
Basic UDI-DI: B-08426950627821
Reference: 701255
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash® ENA7 Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950566373
Basic UDI-DI: B-08426950566373
Reference: 701258
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

ENA Assay Kit (Fluorescence Immunoassay)

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225992
Basic UDI-DI: B-06975424225992
Reference: DL2515301C
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

ENA Assay Kit (Fluorescence Immunoassay)

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225206
Basic UDI-DI: B-06975424225206
Reference: DL2515301
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay ENA Screen IgG (CLIA)

Sharay ENA Screen IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769826
Basic UDI-DI: B-06975070769826
Reference: 14000786
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay ENA Screen IgG (CLIA)

100 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070765385
Basic UDI-DI: B-06975070765385
Reference: 18155001
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Ireland
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:40

Manufacturer products Authorised representative products Authorised representative actors View details

ENA Screen FIA Kit

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892251
Basic UDI-DI: B-06974674892251
Reference: 18-02-0055
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:13

Manufacturer products Authorised representative products Authorised representative actors View details

ENA Screen 6 ELISA

ENA Screen 6 ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325004443
Basic UDI-DI: B-04049325004443
Reference: RE75411
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:09

Manufacturer products View details

ENA-LISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672001339
Basic UDI-DI: B-03532672001339
Reference: HM 008
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:42

Manufacturer products View details

Evo Autoimmune SPA

Evo Autoimmune SPA

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 48058945154708
Basic UDI-DI: 8058945153AX3020ENAWF
Reference: 3AX3020 ENA
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:18

Manufacturer products View details

CHORUSENA6

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891323134
Basic UDI-DI: 803389132CHORUSENA6S00BK
Reference: 86012
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:19

Manufacturer products View details

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891329129
Basic UDI-DI: 803389132CHORUSENA6S00BK
Reference: 86012/12
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 07:52

Manufacturer products View details