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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

24.09.2026 21:54

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Device

3624605

Actor

47892

Certificate

3409

Active filter:EMDN:W010208

495 device results listed.

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Clozapine/Aripiprazole/Risperidone/ Olanzapine Kit(LC-MS/MS)

100T

IVD generalIVDDOn the marketKitReagent
Manufacturer
Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN
CN-MF-000050651
UDI-DI
06978945081191
Basic UDI-DI
B-06978945081191
Reference
LAZP910A
EMDN
W01020899
EMDN description
THERAPEUTIC DRUG MONITORING - OTHER
First on market country
Austria
Authorised representative
Medunion S.L.
Last updated
07.07.2026 01:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Valproic Acid and Carbamazepine Kit(LC-MS/MS)

96 T

IVD generalIVDDOn the marketKitReagent
Manufacturer
Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN
CN-MF-000050651
UDI-DI
06978945081184
Basic UDI-DI
B-06978945081184
Reference
LAZP905A
EMDN
W0102080299
EMDN description
CENTRAL NERVOUS SYSTEM TDM - OTHER
First on market country
Austria
Authorised representative
Medunion S.L.
Last updated
07.07.2026 01:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Human Monkeypox Virus (MPV) IgGIgM Antibody Rapid Test Device（Colloidal Gold)

A060501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000037850
UDI-DI
06976753476086
Basic UDI-DI
B-06976753476086
Reference
A060501D
EMDN
W0102080399
EMDN description
ANTIBIOTICS TDM - OTHER
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
07.07.2026 01:00
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Human Monkeypox Virus (MPV) Antigen Rapid Test Device (Colloidal Gold)

A051601D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000037850
UDI-DI
06976753476055
Basic UDI-DI
B-06976753476055
Reference
A051601D
EMDN
W0102080399
EMDN description
ANTIBIOTICS TDM - OTHER
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
07.07.2026 01:00
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SARS-Cov-2＆ FLU A&B & RSV & Adv Combo Rapid Test Cassett(swab)

A141301D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000037850
UDI-DI
06976753472958
Basic UDI-DI
B-06976753472958
Reference
A141301D
EMDN
W0102080399
EMDN description
ANTIBIOTICS TDM - OTHER
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
07.07.2026 00:58
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Respiratory Syncytial Viral Rapid Test Device (Swab)

A081301D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000037850
UDI-DI
06976753472651
Basic UDI-DI
B-06976753472651
Reference
A081301D
EMDN
W0102080399
EMDN description
ANTIBIOTICS TDM - OTHER
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
07.07.2026 00:58
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Digoxin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

200 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN
CN-MF-000025964
UDI-DI
06974969983022
Basic UDI-DI
B-06974969983022
Reference
200 Tests/kit（DR1159-3）
EMDN
W0102080101
EMDN description
DIGOXIN
First on market country
Germany
Authorised representative
Luxus Lebenswelt GmbH
Last updated
06.07.2026 21:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Digoxin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

100 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN
CN-MF-000025964
UDI-DI
06974969983015
Basic UDI-DI
B-06974969983015
Reference
100 Tests/kit（DR1159-2）
EMDN
W0102080101
EMDN description
DIGOXIN
First on market country
Germany
Authorised representative
Luxus Lebenswelt GmbH
Last updated
06.07.2026 21:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Digoxin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN
CN-MF-000025964
UDI-DI
06974969983008
Basic UDI-DI
B-06974969983008
Reference
50 Tests/kit（DR1159-1）
EMDN
W0102080101
EMDN description
DIGOXIN
First on market country
Germany
Authorised representative
Luxus Lebenswelt GmbH
Last updated
06.07.2026 21:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Procise IFX Assay

Procise IFX Assay

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000014073
UDI-DI
03532678603551
Basic UDI-DI
B-03532678603551
Reference
4828_
EMDN
W0102080701
EMDN description
INFLIXIMAB
First on market country
France
Authorised representative
-
Last updated
05.07.2026 16:47
Manufacturer productsView details
Procise ADL Assay

Procise ADL Assay

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000014073
UDI-DI
03532678603520
Basic UDI-DI
B-03532678603520
Reference
4853_
EMDN
W0102080702
EMDN description
ADALIMUMAB
First on market country
France
Authorised representative
-
Last updated
05.07.2026 16:47
Manufacturer productsView details
LISA-TRACKER Anti-Secukinumab

LISA-TRACKER Anti-Secukinumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000042615
UDI-DI
03532672000875
Basic UDI-DI
B-03532672000875
Reference
LTS 003-48
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
France
Authorised representative
-
Last updated
05.07.2026 16:40
Manufacturer productsView details
LISA-TRACKER Secukinumab

LISA-TRACKER Secukinumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000042615
UDI-DI
03532672000868
Basic UDI-DI
B-03532672000868
Reference
LTS 002-48
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
France
Authorised representative
-
Last updated
05.07.2026 16:40
Manufacturer productsView details
LISA-TRACKER Duo-Vedolizumab

LISA-TRACKER Duo-Vedolizumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000042615
UDI-DI
03532672000851
Basic UDI-DI
B-03532672000851
Reference
LTV 005
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
France
Authorised representative
-
Last updated
05.07.2026 16:40
Manufacturer productsView details
LISA-TRACKER Anti-Vedolizumab

LISA-TRACKER Anti-Vedolizumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000042615
UDI-DI
03532672000844
Basic UDI-DI
B-03532672000844
Reference
LTV 003-48
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
France
Authorised representative
-
Last updated
05.07.2026 16:40
Manufacturer productsView details
LISA-TRACKER Anti-Ustekinumab

LISA-TRACKER Anti-Ustekinumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000042615
UDI-DI
03532672000813
Basic UDI-DI
B-03532672000813
Reference
LTU 003-48
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
France
Authorised representative
-
Last updated
05.07.2026 16:40
Manufacturer productsView details
LISA-TRACKER Vedolizumab

LISA-TRACKER Vedolizumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000042615
UDI-DI
03532672000837
Basic UDI-DI
B-03532672000837
Reference
LTV 002-48
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
France
Authorised representative
-
Last updated
05.07.2026 16:40
Manufacturer productsView details
LISA-TRACKER Duo-Ustekinumab

LISA-TRACKER Duo-Ustekinumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000042615
UDI-DI
03532672000820
Basic UDI-DI
B-03532672000820
Reference
LTU 005
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
France
Authorised representative
-
Last updated
05.07.2026 16:40
Manufacturer productsView details
LISA-TRACKER Ustekinumab

LISA-TRACKER Ustekinumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000042615
UDI-DI
03532672000806
Basic UDI-DI
B-03532672000806
Reference
LTU 002-48
EMDN
W0102080799
EMDN description
AUTOIMMUNE DISEASE TDM - OTHER
First on market country
France
Authorised representative
-
Last updated
05.07.2026 16:40
Manufacturer productsView details