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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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17.07.2026 01:19

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Active filter:Manufacturer SRN:ES-MF-000001005

21 device results listed.

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Promonitor-RTX

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457521
Basic UDI-DI: B-08437013457521
Reference: 5130230000
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-GLM

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457514
Basic UDI-DI: B-08437013457514
Reference: 5200230000
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-ETN

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457507
Basic UDI-DI: B-08437013457507
Reference: 5120230000
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-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

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

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

Manufacturer products View details

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

A1AT Genotyping Test

A1AT Genotyping Test ANALYSIS SOFTWARE

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457705
Basic UDI-DI: 8437013457Gentest004QR
Reference: 1292320000/1292380000
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details

ID HPA XT

ID HPA XT ANALYSIS SOFTWARE

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457699
Basic UDI-DI: 8437013457Gentest003QP
Reference: 1010220034
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details

ID HPA XT Reagents

ID HPA XT

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457279
Basic UDI-DI: 8437013457Gentest002QM
Reference: 1010220034
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details

A1AT Genotyping Test Reagents

A1AT Genotyping Test

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457101
Basic UDI-DI: 8437013457Gentest001QK
Reference: 1292320000
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details