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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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01.08.2026 09:11

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131 device results listed.

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GATA-3

CM405A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627007391
Basic UDI-DI: B-00847627007391
Reference: CM405A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

FOXP3(86D)

API3197AA

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627004727
Basic UDI-DI: B-00847627004727
Reference: API3197AA
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Hungary
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

GATA-3

ALI405G7

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627027177
Basic UDI-DI: B-00847627027177
Reference: ALI405G7
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Galectin-3

API3174AA

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627004598
Basic UDI-DI: B-00847627004598
Reference: API3174AA
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

FOXP3(86D)

ACI3197C

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627003577
Basic UDI-DI: B-00847627003577
Reference: ACI3197C
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Hungary
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Galectin-3

ACI3174B

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627003454
Basic UDI-DI: B-00847627003454
Reference: ACI3174B
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Galectin-3

ACI3174A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627003447
Basic UDI-DI: B-00847627003447
Reference: ACI3174A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

FOXP3

API3164AA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627004505
Basic UDI-DI: B-00847627004505
Reference: API3164AA
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Hungary
Authorised representative: Emergo Europe B.V.
Last updated: 22.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

FOXP3(86D)

ACI3197A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627003560
Basic UDI-DI: B-00847627003560
Reference: ACI3197A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Hungary
Authorised representative: Emergo Europe B.V.
Last updated: 22.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Folate Receptor alpha IHC Assay Kit

IPI4006KG10

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627008985
Basic UDI-DI: B-00847627008985
Reference: IPI4006KG10
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 22.07.2026 06:42

Manufacturer products Authorised representative products Authorised representative actors View details

Folate Receptor alpha IHC Assay Kit

BRI4006KAA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005182
Basic UDI-DI: B-00847627005182
Reference: BRI4006KAA
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 22.07.2026 06:42

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395]

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

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233014559
Basic UDI-DI: 06152338309JF
Reference: 8379-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-OCT3/4 Mouse Monoclonal Antibody [C-10]

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

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233014481
Basic UDI-DI: 06152338306J9
Reference: 8288-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-TRPS1 Rabbit Polyclonal Antibody [ZR382]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233013996
Basic UDI-DI: 06152338310HY
Reference: 8359-M250
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-Cadherin 17 Rabbit Monoclonal Antibody [QR098] RTU, 10 capsules; 1 pack

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

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233013965
Basic UDI-DI: 06152338300HV
Reference: 8364-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-SALL4 Mouse Monoclonal Antibody [6E3]

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

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233011435
Basic UDI-DI: 06152338307JB
Reference: 8358-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-GATA3 Rabbit Monoclonal Antibody [QR018]

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

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233011428
Basic UDI-DI: 06152338298K3
Reference: 8357-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-SATB2 Rabbit Monoclonal Antibody [QR023]

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

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233011350
Basic UDI-DI: 06152338291JM
Reference: 8356-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233011312
Basic UDI-DI: 06152338304J5
Reference: 8337-M250
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-MUC2 Mouse Monoclonal Antibody [CCP58]

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

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233010711
Basic UDI-DI: 06152338302HZ
Reference: 8305-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details