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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

PR3 IgG (eCLIA)

100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320517903XD
Basic UDI-DI: B-0320517903XD
Reference: 0320517903
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

PR3 IgG (eCLIA)

2×50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320517902XB
Basic UDI-DI: B-0320517902XB
Reference: 0320517902
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

PR3 IgG (eCLIA)

50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320517901X9
Basic UDI-DI: B-0320517901X9
Reference: 0320517901
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

QUANTA Flash PR3 Reagents

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

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950627692
Basic UDI-DI: 84269506276929C
Reference: 701135
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:11

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash PR3 Reagents

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

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950544258
Basic UDI-DI: 84269505442588C
Reference: 701138
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

08034049110910

Anti PR-3 (c-ANCA)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Dia.Metra Srl
Manufacturer SRN: IT-MF-000027206
UDI-DI: 08034049110910
Basic UDI-DI: 8034049110910V7
Reference: DKO091
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:24

Manufacturer products View details

EliA PR3S Well

EliA PR3S

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

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014777
Basic UDI-DI: 7333066BUDI0099MT
Reference: 14-5536-01
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

Manufacturer products View details

06950617403173

IM4410457 IM4411457 IM4414457 IM4415457

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403173
Basic UDI-DI: 69506174IM441457EC
Reference: IM4415457
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details