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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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12.10.2026 08:43

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ACI3115B

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627003010
Basic UDI-DI: B-00847627003010
Reference: ACI3115B
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:14

Manufacturer products Authorised representative products Authorised representative actors View details

ACI3115A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627003003
Basic UDI-DI: B-00847627003003
Reference: ACI3115A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Greece
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:14

Manufacturer products Authorised representative products Authorised representative actors View details

ACI3110B

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002952
Basic UDI-DI: B-00847627002952
Reference: CD71
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:14

Manufacturer products Authorised representative products Authorised representative actors View details

ACI3110A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002945
Basic UDI-DI: B-00847627002945
Reference: ACI3110A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:14

Manufacturer products Authorised representative products Authorised representative actors View details

Topoisomerase II alpha

ACI3045B

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002792
Basic UDI-DI: B-00847627002792
Reference: ACI3045B
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Greece
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:13

Manufacturer products Authorised representative products Authorised representative actors View details

Topoisomerase II alpha

ACI3045A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002785
Basic UDI-DI: B-00847627002785
Reference: ACI3045A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:13

Manufacturer products Authorised representative products Authorised representative actors View details

ACI3043C

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002778
Basic UDI-DI: B-00847627002778
Reference: ACI3043C
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:13

Manufacturer products Authorised representative products Authorised representative actors View details

ACI3043A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002761
Basic UDI-DI: B-00847627002761
Reference: ACI3043A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:13

Manufacturer products Authorised representative products Authorised representative actors View details

ACI3030B

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002716
Basic UDI-DI: B-00847627002716
Reference: ACI3030B
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Sweden
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:13

Manufacturer products Authorised representative products Authorised representative actors View details

ACI3030A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002709
Basic UDI-DI: B-00847627002709
Reference: ACI3030A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:13

Manufacturer products Authorised representative products Authorised representative actors View details

Glutamine Synthetase

ACI3009B

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002594
Basic UDI-DI: B-00847627002594
Reference: ACI3009B
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:13

Manufacturer products Authorised representative products Authorised representative actors View details

Glutamine Synthetase

ACI3009A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002587
Basic UDI-DI: B-00847627002587
Reference: ACI3009A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:13

Manufacturer products Authorised representative products Authorised representative actors View details

ACI3008B

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002570
Basic UDI-DI: B-00847627002570
Reference: ACI3008B
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:12

Manufacturer products Authorised representative products Authorised representative actors View details

ACI3008A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002563
Basic UDI-DI: B-00847627002563
Reference: ACI3008A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:12

Manufacturer products Authorised representative products Authorised representative actors View details

ACI259A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002556
Basic UDI-DI: B-00847627002556
Reference: ACI259A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:12

Manufacturer products Authorised representative products Authorised representative actors View details

Estrogen Receptor (ER) [6F11+SP1]

API308H

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002273
Basic UDI-DI: B-00847627002273
Reference: API308H
EMDN: W0102030201
EMDN description: ESTROGEN RECEPTOR ASSAYS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:12

Manufacturer products Authorised representative products Authorised representative actors View details

Estrogen Receptor (ER) [6F11+SP1]

API308AA

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002266
Basic UDI-DI: B-00847627002266
Reference: API308AA
EMDN: W0102030201
EMDN description: ESTROGEN RECEPTOR ASSAYS
First on market country: Hungary
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:12

Manufacturer products Authorised representative products Authorised representative actors View details

Estrogen Receptor (ER) [6F11]

API093AA

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002051
Basic UDI-DI: B-00847627002051
Reference: API093AA
EMDN: W0102030201
EMDN description: ESTROGEN RECEPTOR ASSAYS
First on market country: Hungary
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:12

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema pallidum (Spirochete)

API135AA

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002075
Basic UDI-DI: B-00847627002075
Reference: API135AA
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:12

Manufacturer products Authorised representative products Authorised representative actors View details

CRM352B

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627001856
Basic UDI-DI: B-00847627001856
Reference: CRM352B
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 11.10.2026 02:11

Manufacturer products Authorised representative products Authorised representative actors View details