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93 device results listed.

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ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500545
Basic UDI-DI: B-08012992500545
Reference: 50054
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500538
Basic UDI-DI: B-08012992500538
Reference: 50053
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

Anti-PR3 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: 06975424225633
Basic UDI-DI: B-06975424225633
Reference: DL234601C
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-MPO 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: 06975424225626
Basic UDI-DI: B-06975424225626
Reference: DL234501C
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223936
Basic UDI-DI: B-06975424223936
Reference: DL234606
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223929
Basic UDI-DI: B-06975424223929
Reference: DL234506
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-PR3 Assay Kit (Fluorescence Immunoassay)

20T

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424221857
Basic UDI-DI: B-06975424221857
Reference: 20T
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:37

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-MPO Assay Kit (Fluorescence Immunoassay)

20T

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424221840
Basic UDI-DI: B-06975424221840
Reference: 20T
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:37

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-MPO IgG (CLIA)

Sharay Anti-MPO IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769314
Basic UDI-DI: B-06975070769314
Reference: 14000722
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-PR3 IgG (CLIA)

Sharay Anti-PR3 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769307
Basic UDI-DI: B-06975070769307
Reference: 14000878
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-PR3 IgG (CLIA)

Sharay Anti-PR3 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761035
Basic UDI-DI: B-06975070761035
Reference: 18102001
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-MPO IgG (CLIA)

Sharay Anti-MPO IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761011
Basic UDI-DI: B-06975070761011
Reference: 18103001
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

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

PR3 IgG (c-ANCA) capture ELISA

PR3 IgG (c-ANCA) capture ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325014343
Basic UDI-DI: B-04049325014343
Reference: 30112111
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:11

Manufacturer products View details

FIDIS Vasculitis

FIDIS Vasculitis

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672001384
Basic UDI-DI: B-03532672001384
Reference: MX 007
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:42

Manufacturer products View details

PR3 IgG (eCLIA)

200T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSelf testing

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320517904XF
Basic UDI-DI: B-0320517904XF
Reference: 0320517904
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:34

Manufacturer products Authorised representative products Authorised representative actors View details