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492 device results listed.

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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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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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Mobile Phase A

DOSIMMUNE

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: SHIMADZU CHEMISTRY AND DIAGNOSTICS
Manufacturer SRN: FR-MF-000048960
UDI-DI: 03770029302023
Basic UDI-DI: 3770029302IMK00TU
Reference: 227-40102-55
EMDN: W0102080699
EMDN description: IMMUNOSUPPRESSANT TDM - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:12

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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

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

INDITREAT CRC EXPLORE ARRAY

IndiTreat® ARRAYS

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: 2cureX A/S
Manufacturer SRN: DK-MF-000036335
UDI-DI: 29418000012cxEXP
Basic UDI-DI: 232118324ARRAYSZK
Reference: 2CX-CRCEXP-01
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 01.07.2026 12:09

Manufacturer products View details

Valproic Acid Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06975182500249
Basic UDI-DI: 697518250P114076C
Reference: P11407
EMDN: W0102080210
EMDN description: VALPROIC ACID
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Digoxin Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06975182500232
Basic UDI-DI: 697518250P114015Y
Reference: P11401
EMDN: W0102080101
EMDN description: DIGOXIN
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Trazodone Rapid Test

TZD-U11, TZD-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817510
Basic UDI-DI: B-06952804817510
Reference: TZD-U11 TZD-U23
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Zolpidem

ZOL-U11, ZOL-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817343
Basic UDI-DI: B-06952804817343
Reference: ZOL-U11, ZOL-U23
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Methylphenidate

MPD-U11, MPD-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817145
Basic UDI-DI: B-06952804817145
Reference: MPD-U11 MPD-U23
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details