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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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154 device results listed.

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i-Tracker Anti-Rituximab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000158
Basic UDI-DI: B-03532672000158
Reference: CTR 003-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:39

Manufacturer products View details

i-Tracker Rituximab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000141
Basic UDI-DI: B-03532672000141
Reference: CTR 002-50
EMDN: W0102080704
EMDN description: RITUXIMAB
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:39

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i-Tracker Anti-Golimumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000134
Basic UDI-DI: B-03532672000134
Reference: CTG 003-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:39

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i-Tracker Golimumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000127
Basic UDI-DI: B-03532672000127
Reference: CTG 002-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:39

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i-Tracker Anti-Certolizumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000097
Basic UDI-DI: B-03532672000097
Reference: CTC 003-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:39

Manufacturer products View details

i-Tracker Certolizumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000080
Basic UDI-DI: B-03532672000080
Reference: CTC 002-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:39

Manufacturer products View details

i-Tracker Anti-Vedolizumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000073
Basic UDI-DI: B-03532672000073
Reference: CTV 003-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:39

Manufacturer products View details

i-Tracker Vedolizumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000066
Basic UDI-DI: B-03532672000066
Reference: CTV 002-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

i-Tracker Anti-Ustekinumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000059
Basic UDI-DI: B-03532672000059
Reference: CTU 003-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

i-Tracker Anti-Infliximab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000035
Basic UDI-DI: B-03532672000035
Reference: CTI 003-100
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

i-Tracker Infliximab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000028
Basic UDI-DI: B-03532672000028
Reference: CTI 002-100
EMDN: W0102080701
EMDN description: INFLIXIMAB
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

i-Tracker Anti-Adalimumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000011
Basic UDI-DI: B-03532672000011
Reference: CTA 003-100
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

i-Tracker Adalimumab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000004
Basic UDI-DI: B-03532672000004
Reference: CTA 002-100
EMDN: W0102080702
EMDN description: ADALIMUMAB
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

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