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

22.09.2026 16:13

Sync status

Successful

Device

3537230

Actor

47759

Certificate

3388

Filters

Show filters

Active filter:EMDN:W01021004

115 device results listed.

Page 5 / 6

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

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

MPO IgG (eCLIA)

200T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320517804XA
Basic UDI-DI: B-0320517804XA
Reference: 0320517804
EMDN: W0102100402
EMDN description: MPO 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

MPO IgG (eCLIA)

100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320517803X8
Basic UDI-DI: B-0320517803X8
Reference: 0320517803
EMDN: W0102100402
EMDN description: MPO 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

MPO IgG (eCLIA)

2×50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320517802X6
Basic UDI-DI: B-0320517802X6
Reference: 0320517802
EMDN: W0102100402
EMDN description: MPO 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

MPO IgG (eCLIA)

50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320517801X4
Basic UDI-DI: B-0320517801X4
Reference: 0320517801
EMDN: W0102100402
EMDN description: MPO 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

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

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

Anti MPO (p-ANCA)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Dia.Metra Srl
Manufacturer SRN: IT-MF-000027206
UDI-DI: 08034049110927
Basic UDI-DI: 8034049110927VQ
Reference: DKO092
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:24

Manufacturer products View details

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

CHORUSMPO

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: 08033891323530
Basic UDI-DI: 803389132CHORUSMPO00BD
Reference: 86068
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:19

Manufacturer products View details

MosaiQ® AiPlex VAS

1x250, 4x85

IVD Class BIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: AliveDx Suisse SA
Manufacturer SRN: CH-MF-000024025
UDI-DI: 07640327462186
Basic UDI-DI: 764032746AIPLEXVASMAG7P
Reference: 160040
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

EliA MPOS

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

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014784
Basic UDI-DI: 7333066BUDI0100LK
Reference: 14-5537-01
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

Manufacturer products View details

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

IM4410459 IM4411459 IM4414459 IM4415459

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403630
Basic UDI-DI: 69506174IM441459EG
Reference: IM4415459
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410459 IM4411459 IM4414459 IM4415459

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403623
Basic UDI-DI: 69506174IM441459EG
Reference: IM4414459
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410459 IM4411459 IM4414459 IM4415459

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403616
Basic UDI-DI: 69506174IM441459EG
Reference: IM4411459
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details