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

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173 device results listed.

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i-Tracker Ustekinumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672001964
Basic UDI-DI: 353267CTU002BXB
Reference: CTU 002-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

IMMUNO-TROL i-Tracker Anti-Infliximab Total Ab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672001537
Basic UDI-DI: 353267CTI003TPCA65
Reference: CTI 003T-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

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IMMUNO-TROL i-Tracker Anti-Adalimumab Total Ab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672001520
Basic UDI-DI: 353267CTA003TPCAZA
Reference: CTA 003T-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

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IMMUNO-TROL i-Tracker Anti-Ocrelizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000479
Basic UDI-DI: 353267CTO003PCAX5
Reference: CTO 003-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

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IMMUNO-TROL i-Tracker Ocrelizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000462
Basic UDI-DI: 353267CTO002PCAWW
Reference: CTO 002-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

IMMUNO-TROL i-Tracker Anti-Risankizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000431
Basic UDI-DI: 353267CTRZ003PCAR8
Reference: CTRZ 003-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

IMMUNO-TROL i-Tracker Risankizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000424
Basic UDI-DI: 353267CTRZ002PCAQZ
Reference: CTRZ 002-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

IMMUNO-TROL i-Tracker Anti-Etanercept

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000370
Basic UDI-DI: 353267CTE003PCART
Reference: CTE 003-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

IMMUNO-TROL i-Tracker Etanercept

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000363
Basic UDI-DI: 353267CTE002PCARL
Reference: CTE 002-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

i-Tracker Anti-Adalimumab Total Ab

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000257
Basic UDI-DI: 353267CTA003TAPH
Reference: CTA 003T-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

i-Tracker Anti-Ocrelizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000219
Basic UDI-DI: 353267CTO003AVA
Reference: CTO 003-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

i-Tracker Ocrelizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000202
Basic UDI-DI: 353267CTO002AV7
Reference: CTO 002-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

i-Tracker Anti-Infliximab Total Ab

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000240
Basic UDI-DI: 353267CTI003TASR
Reference: CTI 003T-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

i-Tracker Anti-Risankizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000172
Basic UDI-DI: 353267CTRZ003A95
Reference: CTRZ 003-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

i-Tracker Risankizumab

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

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000165
Basic UDI-DI: 353267CTRZ002A92
Reference: CTRZ 002-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

i-Tracker Anti-Etanercept

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000110
Basic UDI-DI: 353267CTE003ARU
Reference: CTE 003-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

i-Tracker Etanercept

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000103
Basic UDI-DI: 353267CTE002ARR
Reference: CTE 002-50
EMDN: W0102080703
EMDN description: ETANERCEP
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

i-Tracker Adalimumab

IVD generalNot specifiedOn the market

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000004
Basic UDI-DI: B-03532672000004
Reference: CTA 002-100
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: -
Last updated: 28.06.2026 11:40

Manufacturer products View details

i-Tracker Anti-Adalimumab

IVD generalNot specifiedOn the market

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000011
Basic UDI-DI: B-03532672000011
Reference: CTA 003-100
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: -
Last updated: 28.06.2026 11:40

Manufacturer products View details

i-Tracker Infliximab

IVD generalNot specifiedOn the market

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000028
Basic UDI-DI: B-03532672000028
Reference: CTI 002-100
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: -
Last updated: 28.06.2026 11:40

Manufacturer products View details