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EUDAMED Device Search

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

Last updated

01.08.2026 18:27

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22 device results listed.

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BlueDiverDot ANCA+GBM IgG

BlueDiverDot ANCA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681350
Basic UDI-DI: 542502368BDDANCA4F
Reference: ANCAGDIV-24
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot ANCA+GBM IgG

BlueDot ANCA+GBM

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680353
Basic UDI-DI: 542502368BDANCAYR
Reference: ANCAGD-24
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

ANCA-Pro

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147154776
Basic UDI-DI: B-86060147154776
Reference: N261A24ACA
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 29.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Neutrophil Cytoplasmic Antibody (Formalin Fixed)

A060PL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ZEUS Scientific
Manufacturer SRN: US-MF-000026845
UDI-DI: D-A060PLX4
Basic UDI-DI: B-A060PLX4
Reference: A060PL
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Neutrophil Cytoplasmic Antibody (Ethanol Fixed)

A060L

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ZEUS Scientific
Manufacturer SRN: US-MF-000026845
UDI-DI: D-A060LMJ
Basic UDI-DI: B-A060LMJ
Reference: A060L
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA Lite® DAPI ANCA Ethanol

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950767053
Basic UDI-DI: B-08426950767053
Reference: 704338
EMDN: W0102100401
EMDN description: ANCA 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

NOVA Lite® DAPI ANCA Formalin

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950767046
Basic UDI-DI: B-08426950767046
Reference: 704337
EMDN: W0102100401
EMDN description: ANCA 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

NOVA Lite® ANCA Formalin Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950594109
Basic UDI-DI: B-08426950594109
Reference: 708297
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA Lite® ANCA Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950594055
Basic UDI-DI: B-08426950594055
Reference: 708299
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA Lite® ANCA Formalin Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950554103
Basic UDI-DI: B-08426950554103
Reference: 708295
EMDN: W0102100401
EMDN description: ANCA 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

NOVA Lite® ANCA Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950513995
Basic UDI-DI: B-08426950513995
Reference: 708296
EMDN: W0102100401
EMDN description: ANCA 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

NOVA Lite® ANCA Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950512912
Basic UDI-DI: B-08426950512912
Reference: 708298
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA Lite® ANCA Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950456216
Basic UDI-DI: B-08426950456216
Reference: 708290
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

AESKUSLIDES® ANCA Formalin

AESKUSLIDES® ANCA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289504775
Basic UDI-DI: B-04250289504775
Reference: 54.051
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:39

Manufacturer products View details

AESKUSLIDES® ANCA Ethanol

AESKUSLIDES® ANCA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289504751
Basic UDI-DI: B-04250289504751
Reference: 54.050
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:39

Manufacturer products View details

AESKUBLOTS® Vasculitis Pro

AESKUBLOTS® Vasculitis Pro

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289504522
Basic UDI-DI: B-04250289504522
Reference: 4002
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:39

Manufacturer products View details

AESKUSLIDES® ANCA Formalin

AESKUSLIDES® ANCA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289503839
Basic UDI-DI: B-04250289503839
Reference: 54.101
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:39

Manufacturer products View details

AESKUSLIDES® ANCA Ethanol

AESKUSLIDES® ANCA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289503822
Basic UDI-DI: B-04250289503822
Reference: 54.100
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:39

Manufacturer products View details

Vasculitis – ANCA + GBM Dot

-

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687192
Basic UDI-DI: 542502368BDANCAYR
Reference: AD MPGD
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

Vasculitis - ANCA+GBM

-

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687499
Basic UDI-DI: 542502368BDDANCA4F
Reference: AD MPGDBD
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details