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EUDAMED Device Search

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

TREN

Last updated

01.08.2026 18:27

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Device

2990209

Actor

47523

Certificate

3174

Active filter:EMDN:W01020807

154 device results listed.

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Anti-adalimumab Antibody Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile
Manufacturer
Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN
CN-MF-000019511
UDI-DI
06942293581368
Basic UDI-DI
697518250P114296N
Reference
P11429
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
Italy
Authorised representative
Medunion S.L.
Last updated
26.06.2026 19:25
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Infliximab  Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile
Manufacturer
Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN
CN-MF-000019511
UDI-DI
06942293581306
Basic UDI-DI
697518250P114236A
Reference
P11423
EMDN
W0102080701
EMDN description
INFLIXIMAB
First on market country
Italy
Authorised representative
Medunion S.L.
Last updated
26.06.2026 19:25
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Adalimumab Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile
Manufacturer
Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN
CN-MF-000019511
UDI-DI
06942293581283
Basic UDI-DI
697518250P114246C
Reference
P11424
EMDN
W0102080702
EMDN description
ADALIMUMAB
First on market country
Italy
Authorised representative
Medunion S.L.
Last updated
26.06.2026 19:25
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Certolizumab 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
06942293552337
Basic UDI-DI
697518250F114712K
Reference
F11471
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
Italy
Authorised representative
Medunion S.L.
Last updated
26.06.2026 19:21
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Free Anti-Etanercept 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
06942293552313
Basic UDI-DI
697518250F114672U
Reference
F11467
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
Italy
Authorised representative
Medunion S.L.
Last updated
26.06.2026 19:21
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Etanercept 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
06942293552290
Basic UDI-DI
697518250P114666U
Reference
F11466
EMDN
W0102080703
EMDN description
ETANERCEP
First on market country
Italy
Authorised representative
Medunion S.L.
Last updated
26.06.2026 19:21
Manufacturer productsAuthorised representative productsAuthorised representative actorsView 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
06942293552252
Basic UDI-DI
697518250P1146972
Reference
F11447
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
Italy
Authorised representative
Medunion S.L.
Last updated
26.06.2026 19:21
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Free Anti-Tocilizumab 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
06942293551408
Basic UDI-DI
697518250F114742R
Reference
F11472
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
Italy
Authorised representative
Medunion S.L.
Last updated
26.06.2026 19:21
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Tocilizumab 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
06942293551385
Basic UDI-DI
697518250F114732P
Reference
F11432
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
Italy
Authorised representative
Medunion S.L.
Last updated
26.06.2026 19:21
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Free Anti-Certolizumab 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
06942293551378
Basic UDI-DI
697518250F114722M
Reference
F11472
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
Italy
Authorised representative
Medunion S.L.
Last updated
26.06.2026 19:21
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
LISA-TRACKER Duo Tocilizumab

-

IVD generalNot specifiedOn the market
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000042615
UDI-DI
03532672000776
Basic UDI-DI
B-03532672000776
Reference
LTT 005
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
France
Authorised representative
-
Last updated
17.06.2026 02:01
Manufacturer productsView details
LISA-TRACKER Anti-Tocilizumab

-

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000042615
UDI-DI
03532672000752
Basic UDI-DI
B-03532672000752
Reference
LTT 003-48
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
France
Authorised representative
-
Last updated
17.06.2026 01:59
Manufacturer productsView details
04049095070174

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
R-Biopharm AG
Manufacturer SRN
DE-MF-000007993
UDI-DI
04049095070174
Basic UDI-DI
4049095GN30410000AN
Reference
GP3041
EMDN
W0102080701
EMDN description
INFLIXIMAB
First on market country
-
Authorised representative
-
Last updated
16.06.2026 22:40
Manufacturer productsView details
04049095070211

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
R-Biopharm AG
Manufacturer SRN
DE-MF-000007993
UDI-DI
04049095070211
Basic UDI-DI
4049095GN30430000BC
Reference
GP3043
EMDN
W0102080702
EMDN description
ADALIMUMAB
First on market country
-
Authorised representative
-
Last updated
16.06.2026 22:40
Manufacturer productsView details