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EUDAMED Device Search

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

Last updated

04.08.2026 18:01

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475 device results listed.

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Promonitor-ETN

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457491
Basic UDI-DI: B-08437013457491
Reference: 5110230000
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:52

Manufacturer products View details

Promonitor-ANTI-GLM

Promonitor-ANTI-GLM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457354
Basic UDI-DI: B-08437013457354
Reference: 5210230000
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:52

Manufacturer products View details

09026924190

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 07613336190807
Basic UDI-DI: B-07613336190807
Reference: 09026924190
EMDN: W0102080307
EMDN description: GENTAMICIN
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 07.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

09086137190

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 07613336190753
Basic UDI-DI: B-07613336190753
Reference: 09086137190
EMDN: W0102080307
EMDN description: GENTAMICIN
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 07.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

Methotrexate Control

2Levels×1×1mL

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945081252
Basic UDI-DI: B-06978945081252
Reference: LBZK913A
EMDN: W0102080501
EMDN description: METHOTREXATE
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:57

Manufacturer products Authorised representative products Authorised representative actors View details

Methotrexate Kit(LC-MS/MS)

96T

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945081245
Basic UDI-DI: B-06978945081245
Reference: LAZP912A
EMDN: W0102080501
EMDN description: METHOTREXATE
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:57

Manufacturer products Authorised representative products Authorised representative actors View details

Voriconazole Kit(LC-MS/MS)

96T

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945081221
Basic UDI-DI: B-06978945081221
Reference: LAZP908A
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 products Authorised representative products Authorised representative actors View details

Valproic Acid and Carbamazepine Control

2Levels×1×1mL

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945081207
Basic UDI-DI: B-06978945081207
Reference: LBZK905A
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 products Authorised representative products Authorised representative actors View details

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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View details

Three Immune Inhibitors Kit(LC-MS/MS)

96 T

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945081153
Basic UDI-DI: B-06978945081153
Reference: LAZK902A
EMDN: W0102080699
EMDN description: IMMUNOSUPPRESSANT TDM - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:57

Manufacturer products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View details

IDKmonitor® Infliximab drug level

IDKmonitor® Infliximab drug level

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598006164
Basic UDI-DI: B-04050598006164
Reference: K 9655.20
EMDN: W0102080701
EMDN description: INFLIXIMAB
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:46

Manufacturer products View details

IDKmonitor® Adalimumab drug level ELISA

IDKmonitor® Adalimumab drug level ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598006157
Basic UDI-DI: B-04050598006157
Reference: K 9657.20
EMDN: W0102080702
EMDN description: ADALIMUMAB
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:46

Manufacturer products View details