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EUDAMED Device Search

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

Last updated

23.09.2026 08:13

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Active filter:EMDN:W01021004

115 device results listed.

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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: 06950617403609
Basic UDI-DI: 69506174IM441459EG
Reference: IM4410459
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

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

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: 06950617403166
Basic UDI-DI: 69506174IM441457EC
Reference: IM4414457
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

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: 06950617403159
Basic UDI-DI: 69506174IM441457EC
Reference: IM4410457
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

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: 06950617403142
Basic UDI-DI: 69506174IM441457EC
Reference: IM4411457
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

Anti-MPO IgG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359513258
Basic UDI-DI: 697015090000314HA
Reference: CMQ1610
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-MPO IgG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359513234
Basic UDI-DI: 697015090000314HA
Reference: CMQ1608
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:51

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: 06942359513166
Basic UDI-DI: 697015090000313H8
Reference: CMQ1510
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:50

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: 06942359513142
Basic UDI-DI: 697015090000313H8
Reference: CMQ1508
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Vasculitis – ANCA + GBM Dot

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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

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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

DIASpot ANCA+GBM IgG

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IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023688038
Basic UDI-DI: 542502368BDANCAYR
Reference: KAPDTANCAG
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

DIAspot Neptune ANCA+GBM IgG

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IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023688144
Basic UDI-DI: 542502368BDDANCA4F
Reference: KAPDTANCAGN
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

MosaiQ® AiPlex VAS

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IVD Class BIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: AliveDx Suisse SA
Manufacturer SRN: CH-MF-000024025
UDI-DI: 07640327462209
Basic UDI-DI: 764032746AIPLEXVASMAG7P
Reference: 160041
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 16.06.2026 08:49

Manufacturer products Authorised representative products Authorised representative actors View details

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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: 08033891329426
Basic UDI-DI: 803389132CHORUSMPO00BD
Reference: 86068/12
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 07:52

Manufacturer products View details