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EUDAMED Device Search

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

Last updated

31.07.2026 22:52

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473 device results listed.

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CAT Rapid Test Cassette

CAT Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-DCA-R1023B
Basic UDI-DI: B-DCA-R1023B
Reference: DCA-R102
EMDN: W0102080401
EMDN description: CAFFEINE
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

IDKmonitor® Infliximab free ADA ELISA

IDKmonitor® Infliximab free ADA ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598196506
Basic UDI-DI: B-04050598196506
Reference: K 9650
EMDN: W0102080701
EMDN description: INFLIXIMAB
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

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IDKmonitor® Adalimumab free ADA ELISA

IDKmonitor® Adalimumab free ADA ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598196520
Basic UDI-DI: B-04050598196520
Reference: K 9652
EMDN: W0102080702
EMDN description: ADALIMUMAB
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

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Secukinumab ELISA

710701

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

Manufacturer: Advanced Practical Diagnostics
Manufacturer SRN: BE-MF-000000572
UDI-DI: 05430000412254
Basic UDI-DI: 5430000412710701QC
Reference: 710701
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:05

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Ustekinumab ELISA

710601

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

Manufacturer: Advanced Practical Diagnostics
Manufacturer SRN: BE-MF-000000572
UDI-DI: 05430000412100
Basic UDI-DI: 5430000412710601Q7
Reference: 710601
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:05

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Golimumab ELISA

710401

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

Manufacturer: Advanced Practical Diagnostics
Manufacturer SRN: BE-MF-000000572
UDI-DI: 05430000412094
Basic UDI-DI: 5430000412710401PV
Reference: 710401
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:05

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Vedolizumab ELISA

710501

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

Manufacturer: Advanced Practical Diagnostics
Manufacturer SRN: BE-MF-000000572
UDI-DI: 05430000412070
Basic UDI-DI: 5430000412710501Q2
Reference: 710501
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:05

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Anti-Adalimumab ELISA

710301

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

Manufacturer: Advanced Practical Diagnostics
Manufacturer SRN: BE-MF-000000572
UDI-DI: 05430000412063
Basic UDI-DI: 5430000412710301PQ
Reference: 710301
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:05

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Adalimumab ELISA

710201

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

Manufacturer: Advanced Practical Diagnostics
Manufacturer SRN: BE-MF-000000572
UDI-DI: 05430000412056
Basic UDI-DI: 5430000412710201PK
Reference: 710201
EMDN: W0102080702
EMDN description: ADALIMUMAB
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:05

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Infliximab ELISA

710001

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

Manufacturer: Advanced Practical Diagnostics
Manufacturer SRN: BE-MF-000000572
UDI-DI: 05430000412032
Basic UDI-DI: 5430000412710001P9
Reference: 710001
EMDN: W0102080701
EMDN description: INFLIXIMAB
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:05

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ConcizuTrace™ ELISA

ConcizuTrace™ ELISA

IVD Class CIVDR 2017/746On the marketNo EU repAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218985
Basic UDI-DI: 50552732CCELISA0649X
Reference: CZM10591
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

mAbXmise – Anti-drug antibodies quantification Kit multiplex ANTI-Infliximab & ANTI-Adalimumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Promise proteomics
Manufacturer SRN: FR-MF-000027377
UDI-DI: 03770024131079
Basic UDI-DI: 3770024131INF-ADAX3
Reference: IADA1
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:57

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mAbXmise PNHTDM

mAbXmise – Monoclonal antibodies quantification Kit Eculizumab or Ravulizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Promise proteomics
Manufacturer SRN: FR-MF-000027377
UDI-DI: 03770024131055
Basic UDI-DI: 3770024131PNH-TDM7A
Reference: PNHTDM
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:57

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mAbXmise – Monoclonal antibody quantification Kit Emicizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Promise proteomics
Manufacturer SRN: FR-MF-000027377
UDI-DI: 03770024131048
Basic UDI-DI: 3770024131HEM-TDMYZ
Reference: HTDM
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:57

Manufacturer products View details

mAbXmise – Monoclonal antibodies quantification Kit Multiplex Infliximab, Adalimumab, Obinutuzumab, Secukinumab, Tocilizumab, Ustekinumab, Vedolizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Promise proteomics
Manufacturer SRN: FR-MF-000027377
UDI-DI: 03770024131000
Basic UDI-DI: 3770024131INF-TDM2V
Reference: ITDM2
EMDN: W0102080701
EMDN description: INFLIXIMAB
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:57

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Cyclosporine direct RIA KIT

IM3679

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590220242
Basic UDI-DI: 150995905IM36796Z
Reference: IM3679
EMDN: W0102080601
EMDN description: CYCLOSPORINE TOTAL
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:45

Manufacturer products View details

OSR6404

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590040031
Basic UDI-DI: 150995902OSR6404MV
Reference: OSR6404
EMDN: W0102080101
EMDN description: DIGOXIN
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:30

Manufacturer products View details

OSR6403

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590040024
Basic UDI-DI: 150995902OSR6403MT
Reference: OSR6403
EMDN: W0102080102
EMDN description: DIGITOXIN
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:30

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ADVIA Centaur Cyclosporine

IVDR_67_TTN_DUB-C_C_CsA

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414524450
Basic UDI-DI: 0405686901807VY
Reference: 10335448
EMDN: W0102080602
EMDN description: CYCLOSPORINE SPECIFIC
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Tacrolimus CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293591046
Basic UDI-DI: 697518250F11410ZU
Reference: F11410-50
EMDN: W0102080603
EMDN description: TACROLIMUS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.07.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details