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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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HysenDx 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: 08809975890034
Basic UDI-DI: 88099758902007000182
Reference: HysenDx 200
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 12:51

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

BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214426
Basic UDI-DI: B-06933260214426
Reference: BT2501-HBA1C
EMDN: -
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-AMH

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76324FQ
Basic UDI-DI: B-DC76324FQ
Reference: DC76324
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-AMH

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76325FS
Basic UDI-DI: B-DC76325FS
Reference: DC76325
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-AMH

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76326FU
Basic UDI-DI: B-DC76326FU
Reference: DC76326
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details