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EUDAMED Device Search

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

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01.08.2026 13:11

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473 device results listed.

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Digoxin Reagent (DIGN 2 x 100)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-650182PV
Basic UDI-DI: B-650182PV
Reference: 650182
EMDN: W0102080101
EMDN description: DIGOXIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

Trastuzumab 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: 06942293591503
Basic UDI-DI: 697518250F114392P
Reference: F11439-50
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Free Anti-Rituximab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552269
Basic UDI-DI: 697518250P1146972
Reference: F11447-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-vedolizumab CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552160
Basic UDI-DI: 697518250F114522F
Reference: F11452-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Rituximab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552153
Basic UDI-DI: 697518250F114342D
Reference: F11434-50
EMDN: W0102080704
EMDN description: RITUXIMAB
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Free Anti-Ustekinumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552122
Basic UDI-DI: 697518250F114332B
Reference: F11433-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Ustekinumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552115
Basic UDI-DI: 697518250F1143229
Reference: F11432-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Free Anti-Bevacizumab 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: 06942293552108
Basic UDI-DI: 697518250F114382M
Reference: F11438-50
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Bevacizumab 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: 06942293552092
Basic UDI-DI: 697518250F114372K
Reference: F11437-50
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Infliximab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552085
Basic UDI-DI: 697518250F114292L
Reference: F11429-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Infliximab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552078
Basic UDI-DI: 697518250F114282J
Reference: F11428-50
EMDN: W0102080701
EMDN description: INFLIXIMAB
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Golimumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552061
Basic UDI-DI: 697518250F1143127
Reference: F11431-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Golimumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552047
Basic UDI-DI: 697518250F1143025
Reference: F11430-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Adalimumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552030
Basic UDI-DI: 697518250F114272G
Reference: F11427-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Adalimumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552023
Basic UDI-DI: 697518250F114262E
Reference: F11426-50
EMDN: W0102080702
EMDN description: ADALIMUMAB
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Vedolizumab CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

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

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293551880
Basic UDI-DI: 697518250F114462L
Reference: F11446-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

00884883008991

QMS Omecamtiv Mecarbil Immunoassay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883008991
Basic UDI-DI: 0884883QCDDFRREC15580D4
Reference: 10023163
EMDN: W0102080199
EMDN description: CARDIOVASCULAR TDM - OTHER
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 16.07.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

N Latex aTNFα

IVDR_27_MAR EB_B_N_La_aTNFa

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414615295
Basic UDI-DI: 0405686902178VT
Reference: 10873738
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:36

Manufacturer products View details

Atellica CH Phenytoin (Phny)

IVDR_67_TTN_DUB-C_C_REAG_phny

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596037
Basic UDI-DI: 0405686901761VZ
Reference: 11097510
EMDN: W0102080208
EMDN description: PHENYTOIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Vancomycin (Vanc)

IVDR_67_TTN_DUB-C_C_REAG_VANC_2

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596020
Basic UDI-DI: 0405686901903VV
Reference: 11097511
EMDN: W0102080319
EMDN description: VANCOMYCIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details