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33 device results listed.

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Aptiva® Vasculitis Kits Pack - 3

Aptiva® Vasculitis Kits Pack - 1

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

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126001076
Basic UDI-DI: 0195126001069PU
Reference: 722104
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.08.2026 23:16

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® Vasculitis Kits Pack - 5

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

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126001083
Basic UDI-DI: 0195126001069PU
Reference: 722105
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® Vasculitis Kits Pack - 1

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

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126001069
Basic UDI-DI: 0195126001069PU
Reference: 722103
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 08.08.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, PR3

PR3, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415617
Basic UDI-DI: B-06924030415617
Reference: MY00112C
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, PR3

PR3, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404314
Basic UDI-DI: B-06924030404314
Reference: MY00316
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:02

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, PR3

PR3, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403294
Basic UDI-DI: B-06924030403294
Reference: MY00214
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, PR3

PR3, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402785
Basic UDI-DI: B-06924030402785
Reference: MY00163
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

IDS PR3-II

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169695733
Basic UDI-DI: B-05060169695733
Reference: IS-AI1702II
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-PR3 IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545488
Basic UDI-DI: 697015090000313H8
Reference: CMQ1505
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-PR3 IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545464
Basic UDI-DI: 697015090000313H8
Reference: CMQ1503
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-PR3 IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912719236
Basic UDI-DI: 692591270092HG
Reference: C89016G
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:35

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-PR3 hs

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147157050
Basic UDI-DI: B-86060147157050
Reference: N262A24PR3
EMDN: W0102100403
EMDN description: PR3 ANCA
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

iFlash-PR3 IgG

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723912
Basic UDI-DI: 692591270092HG
Reference: C89016G-S
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors 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

06975424223936

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

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

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)

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

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

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