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EUDAMED Device Search

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48 device results listed.

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Lyme Borrelia IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238911190
Basic UDI-DI: B-06974238911190
Reference: HLYM077T
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 18:00

Manufacturer products Authorised representative products Authorised representative actors View details

Borrelia Burgdorferi Antibody Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910261
Basic UDI-DI: B-06974238910261
Reference: HLYM004T
EMDN: W0105010602
EMDN description: LYME ANTIBODY TOTAL
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

AESKUBLOTS® Borrelia-M

AESKUBLOTS® Borrelia

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289504577
Basic UDI-DI: B-04250289504577
Reference: 4007
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:39

Manufacturer products View details

AESKUBLOTS® Borrelia-G

AESKUBLOTS® Borrelia

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289504560
Basic UDI-DI: B-04250289504560
Reference: 4006
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:39

Manufacturer products View details

MutaPLEX® Borrelia, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598003040
Basic UDI-DI: B-04050598003040
Reference: KG1917032
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:42

Manufacturer products View details

MutaPLEX® Borrelia, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002425
Basic UDI-DI: B-04050598002425
Reference: KG1917096
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:41

Manufacturer products View details

Borrelia 14kDa + OspC IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325002920
Basic UDI-DI: B-04049325002920
Reference: RE57211
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:08

Manufacturer products View details

Borrelia + VlsE IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325002913
Basic UDI-DI: B-04049325002913
Reference: RE57201
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:08

Manufacturer products View details