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154 device results listed.

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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

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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

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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

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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

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CHORUS Promonitor GOLIMUMAB

CHORUSGLM

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891328337
Basic UDI-DI: 803389132CHORUSGLM0085
Reference: 86708
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:19

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CHORUS Promonitor ETANERCEPT

CHORUSETN

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891328313
Basic UDI-DI: 803389132CHORUSETN009C
Reference: 86706
EMDN: W0102080703
EMDN description: ETANERCEP
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:19

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CHORUS Promonitor USTEKINUMAB

CHORUSUTK

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891324506
Basic UDI-DI: 803389132CHORUSUTK00ED
Reference: 86712
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:19

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CHORUS Promonitor ANTI-GOLIMUMAB

CHORUSAGLM

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891328344
Basic UDI-DI: 803389132CHORUSAGLM006J
Reference: 86709
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:15

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Anti-Infliximab ELISA

710101

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Advanced Practical Diagnostics
Manufacturer SRN: BE-MF-000000572
UDI-DI: 05430000412049
Basic UDI-DI: 5430000412710101PE
Reference: 710101
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.07.2026 04:09

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04049095070204

RIDA®QUICK ADM Monitoring

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095070204
Basic UDI-DI: 4049095GN30430000BC
Reference: GN3043
EMDN: W0102080702
EMDN description: ADALIMUMAB
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:50

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04049095070167

RIDA®QUICK IFX Monitoring

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095070167
Basic UDI-DI: 4049095GN30410000AN
Reference: GN3041
EMDN: W0102080701
EMDN description: INFLIXIMAB
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:50

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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

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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

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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

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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

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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

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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

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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