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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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475 device results listed.

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ARK Lacosamide Assay

5033-0001-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003339
Basic UDI-DI: B-00858724003339
Reference: 5033-0001-00
EMDN: W0102080299
EMDN description: CENTRAL NERVOUS SYSTEM TDM - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Voriconazole II Assay

5030-0001-01

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003223
Basic UDI-DI: B-00858724003223
Reference: 5030-0001-01
EMDN: W0102080399
EMDN description: ANTIBIOTICS TDM - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Topiramate Assay

5015-0001-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003001
Basic UDI-DI: B-00858724003001
Reference: 5015-0001-00
EMDN: W0102080213
EMDN description: TOPIRAMATE
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

00380740102715

5P06-21

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00380740102715
Basic UDI-DI: B-00380740102715
Reference: 5P06-21
EMDN: W0102080402
EMDN description: THEOPHYLLINE
First on market country: Germany
Authorised representative: Thermo Fisher Scientific Oy
Last updated: 04.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

00380740102708

5P08-21

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00380740102708
Basic UDI-DI: B-00380740102708
Reference: 5P08-21
EMDN: W0102080208
EMDN description: PHENYTOIN
First on market country: Germany
Authorised representative: Thermo Fisher Scientific Oy
Last updated: 04.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

00380740102692

5P07-21

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00380740102692
Basic UDI-DI: B-00380740102692
Reference: 5P07-21
EMDN: W0102080207
EMDN description: PHENOBARBITAL
First on market country: Germany
Authorised representative: Thermo Fisher Scientific Oy
Last updated: 04.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

00380740102685

5P05-21

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00380740102685
Basic UDI-DI: B-00380740102685
Reference: 5P05-21
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Germany
Authorised representative: Thermo Fisher Scientific Oy
Last updated: 04.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

Promonitor-VDZ

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457569
Basic UDI-DI: 8437013457Promonitor009H7
Reference: 5391530000
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:04

Manufacturer products View details

Promonitor-ANTI-RTX

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457538
Basic UDI-DI: 8437013457Promonitor008H5
Reference: 5140230000
EMDN: W0102080704
EMDN description: RITUXIMAB
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:04

Manufacturer products View details

Promonitor-ANTI-ADL

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457484
Basic UDI-DI: 8437013457Promonitor004GV
Reference: 5090230000
EMDN: W0102080702
EMDN description: ADALIMUMAB
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:04

Manufacturer products View details

Promonitor-ADL

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457477
Basic UDI-DI: 8437013457Promonitor003GT
Reference: 5080230000
EMDN: W0102080702
EMDN description: ADALIMUMAB
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:04

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Promonitor CONTROL-ADL

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457453
Basic UDI-DI: 8437013457Promonitor016H4
Reference: 54415C0000
EMDN: W0102080702
EMDN description: ADALIMUMAB
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:04

Manufacturer products View details

Promonitor CONTROL-IFX

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457446
Basic UDI-DI: 8437013457Promonitor015H2
Reference: 54315C0000
EMDN: W0102080701
EMDN description: INFLIXIMAB
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:04

Manufacturer products View details

Promonitor-ANTI-VDZ

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457408
Basic UDI-DI: 8437013457Promonitor010GQ
Reference: 5401530000
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:04

Manufacturer products View details

Promonitor-ANTI-UTK

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457392
Basic UDI-DI: 8437013457Promonitor014GY
Reference: 5381530000
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:04

Manufacturer products View details

Promonitor-UTK

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457385
Basic UDI-DI: 8437013457Promonitor013GW
Reference: 5371530000
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:04

Manufacturer products View details

Promonitor-ANTI-IFX

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457088
Basic UDI-DI: 8437013457Promonitor002GR
Reference: 5070230000
EMDN: W0102080701
EMDN description: INFLIXIMAB
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:04

Manufacturer products View details

Promonitor-IFX

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457071
Basic UDI-DI: 8437013457Promonitor001GP
Reference: 5060230000
EMDN: W0102080701
EMDN description: INFLIXIMAB
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:04

Manufacturer products View details

Quantia Digitoxin

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740157517
Basic UDI-DI: 8436003070573XU
Reference: 6K40-02
EMDN: W0102080102
EMDN description: DIGITOXIN
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:20

Manufacturer products View details

Alinity c Digitoxin Standard

Alinity c Digitoxin Reagent Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740153618
Basic UDI-DI: 8436003070610X9
Reference: 01R1101
EMDN: W0102080102
EMDN description: DIGITOXIN
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:20

Manufacturer products View details