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44 device results listed.

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ConcizuTrace™ ELISA

IVD Class CIVDR 2017/746On the marketNo EU repAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218985
Basic UDI-DI: 50552732CCELISA0649X
Reference: CZM10591
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

mAbXmise IADA1

mAbXmise – Anti-drug antibodies quantification Kit multiplex ANTI-Infliximab & ANTI-Adalimumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Promise proteomics
Manufacturer SRN: FR-MF-000027377
UDI-DI: 03770024131079
Basic UDI-DI: 3770024131INF-ADAX3
Reference: IADA1
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:57

Manufacturer products View details

mAbXmise PNHTDM

mAbXmise – Monoclonal antibodies quantification Kit Eculizumab or Ravulizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Promise proteomics
Manufacturer SRN: FR-MF-000027377
UDI-DI: 03770024131055
Basic UDI-DI: 3770024131PNH-TDM7A
Reference: PNHTDM
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:57

Manufacturer products View details

mAbXmise HTDM

mAbXmise – Monoclonal antibody quantification Kit Emicizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Promise proteomics
Manufacturer SRN: FR-MF-000027377
UDI-DI: 03770024131048
Basic UDI-DI: 3770024131HEM-TDMYZ
Reference: HTDM
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:57

Manufacturer products View details

mAbXmise GTDM

mAbXmise – Quantification kit Belatacept or Abatacept

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Promise proteomics
Manufacturer SRN: FR-MF-000027377
UDI-DI: 03770024131031
Basic UDI-DI: B-03770024131031
Reference: GTDM
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: France
Authorised representative: -
Last updated: 19.07.2026 20:47

Manufacturer products View details

Trastuzumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293591503
Basic UDI-DI: 697518250F114392P
Reference: F11439-50
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Free Anti-Bevacizumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552108
Basic UDI-DI: 697518250F114382M
Reference: F11438-50
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Bevacizumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552092
Basic UDI-DI: 697518250F114372K
Reference: F11437-50
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

ClinMass®

MS9600

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS9600CR
Basic UDI-DI: B-MS9600CR
Reference: MS9600
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:16

Manufacturer products View details

ClinMass®

MS9000

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS9000BT
Basic UDI-DI: B-MS9000BT
Reference: MS9000
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:16

Manufacturer products View details

ClinMass®

MS9000A

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS9000ASG
Basic UDI-DI: B-MS9000ASG
Reference: MS9000A
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:16

Manufacturer products View details

Oncogramme

ONCOGRAM2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle useSterile

Manufacturer: Oncomedics SAS
Manufacturer SRN: FR-MF-000041783
UDI-DI: D-FRMF000041783ONCOGRAMPA
Basic UDI-DI: B-FRMF000041783ONCOGRAMPA
Reference: ONCOGRAM2
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 21:46

Manufacturer products View details

Voriconazole Kit(LC-MS/MS)

96T

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945081221
Basic UDI-DI: B-06978945081221
Reference: LAZP908A
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:57

Manufacturer products Authorised representative products Authorised representative actors View details

Clozapine/Aripiprazole/Risperidone/ Olanzapine Kit(LC-MS/MS)

100T

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945081191
Basic UDI-DI: B-06978945081191
Reference: LAZP910A
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:57

Manufacturer products Authorised representative products Authorised representative actors 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

Trazodone Rapid Test

TZD-U11, TZD-U23