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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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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

Anti-Infliximab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552085
Basic UDI-DI: 697518250F114292L
Reference: F11429-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - 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

Infliximab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552078
Basic UDI-DI: 697518250F114282J
Reference: F11428-50
EMDN: W0102080701
EMDN description: INFLIXIMAB
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

Anti-Golimumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552061
Basic UDI-DI: 697518250F1143127
Reference: F11431-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - 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

Golimumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552047
Basic UDI-DI: 697518250F1143025
Reference: F11430-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - 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

Anti-Adalimumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552030
Basic UDI-DI: 697518250F114272G
Reference: F11427-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - 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

Adalimumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552023
Basic UDI-DI: 697518250F114262E
Reference: F11426-50
EMDN: W0102080702
EMDN description: ADALIMUMAB
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

Vedolizumab CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

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

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293551880
Basic UDI-DI: 697518250F114462L
Reference: F11446-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - 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

BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214426
Basic UDI-DI: B-06933260214426
Reference: BT2501-HBA1C
EMDN: -
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Inhibin B

IVD generalNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76020EZ
Basic UDI-DI: B-DC76020EZ
Reference: DC76020
EMDN: -
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-SHBG

IVD generalNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76030F4
Basic UDI-DI: B-DC76030F4
Reference: DC76030
EMDN: -
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-hGH

IVD generalNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76029FK
Basic UDI-DI: B-DC76029FK
Reference: DC76029
EMDN: -
EMDN description: HUMAN GROWTH HORMONE
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Gastrin-17

IVD generalNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76027FF
Basic UDI-DI: B-DC76027FF
Reference: DC76027
EMDN: -
EMDN description: GASTRIN
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-tTG IgG

IVD generalNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76032GV7
Basic UDI-DI: B-DC76032GV7
Reference: DC76032G
EMDN: -
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303021901

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611515
Basic UDI-DI: 0697241261IRS-542BF
Reference: 303021901
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303034701-01;303034701-05;303034701-20;303034701-25;303034701-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611492
Basic UDI-DI: 0697241261IRS-552BJ
Reference: 303034701-20
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

06972412611478

303041901

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611478
Basic UDI-DI: 0697241261IRS-572BQ
Reference: 303041901
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-AMH

IVD generalNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76006F7
Basic UDI-DI: B-DC76006F7
Reference: DC76006
EMDN: -
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

tPAI·C Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-tPAIC706-AE5H
Basic UDI-DI: B-tPAIC706-AE5H
Reference: tPAI·C706-AE10Y, tPAI·C706-AE10N, tPAI·C706-AE20Y, tPAI·C706-AE20N
EMDN: W0103020507
EMDN description: TISSUE PLASMINOGEN ACTIVATOR
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details