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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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295 device results listed.

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Coxiella burnetii (Q-Fever) Phase 2 IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE588810O
Basic UDI-DI: B-+ENTIRE588810O
Reference: RE58881
EMDN: W0105011703
EMDN description: COXIELLA BURNETII (Q FEVER)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

Leptospira IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE589310K
Basic UDI-DI: B-+ENTIRE589310K
Reference: RE58931
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

Coxiella burnetii (Q-Fever) Phase 2 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE588710N
Basic UDI-DI: B-+ENTIRE588710N
Reference: RE58871
EMDN: W0105011703
EMDN description: COXIELLA BURNETII (Q FEVER)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

Coxiella burnetii (Q-Fever) Phase 1 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE588510L
Basic UDI-DI: B-+ENTIRE588510L
Reference: RE58851
EMDN: W0105011703
EMDN description: COXIELLA BURNETII (Q FEVER)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIPTETG043DS0S

NovaLisa® Clostridium tetani toxin 5S IgG plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPTETG043DS0S
Basic UDI-DI: B-+ENTIPTETG043DS0S
Reference: PTETG043DS
EMDN: W0105011709
EMDN description: TETANUS (CLOSTRIDIUM T.)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIPTETG0430U

NovaLisa® Clostridium tetani toxin 5S IgG plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPTETG0430U
Basic UDI-DI: B-+ENTIPTETG0430U
Reference: PTETG043
EMDN: W0105011709
EMDN description: TETANUS (CLOSTRIDIUM T.)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIPCORG0090N

NovaLisa® Corynebacterium diphtheriae toxin 5S IgG plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPCORG0090N
Basic UDI-DI: B-+ENTIPCORG0090N
Reference: PCORG009
EMDN: W0105011708
EMDN description: DIPHTERIA (CORYNEBACTERIUM D.)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIPCORG009DS0L

NovaLisa® Corynebacterium diphtheriae toxin 5S IgG plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPCORG009DS0L
Basic UDI-DI: B-+ENTIPCORG009DS0L
Reference: PCORG009DS
EMDN: W0105011708
EMDN description: DIPHTERIA (CORYNEBACTERIUM D.)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTILEPM066004

NovaLisa® Leptospira IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEPM066004
Basic UDI-DI: B-+ENTILEPM066004
Reference: LEPM0660
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTILEPG06600+

NovaLisa® Leptospira IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEPG06600+
Basic UDI-DI: B-+ENTILEPG06600+
Reference: LEPG0660
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTILEPM0660DS02

NovaLisa® Leptospira IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEPM0660DS02
Basic UDI-DI: B-+ENTILEPM0660DS02
Reference: LEPM0660DS
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTIEIA-51890B

Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-51890B
Basic UDI-DI: B-+ENTIEIA-51890B
Reference: EIA-5189
EMDN: W0105011703
EMDN description: COXIELLA BURNETII (Q FEVER)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-51880A

Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-51880A
Basic UDI-DI: B-+ENTIEIA-51880A
Reference: EIA-5188
EMDN: W0105011703
EMDN description: COXIELLA BURNETII (Q FEVER)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-518709

Coxiella burnetii (Q-Fever) Phase 2 IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-518709
Basic UDI-DI: B-+ENTIEIA-518709
Reference: EIA-5187
EMDN: W0105011703
EMDN description: COXIELLA BURNETII (Q FEVER)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTICOX2M060DS07

NovaLisa® Coxiella burnetii (Q-Fever) Phase 2 IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICOX2M060DS07
Basic UDI-DI: B-+ENTICOX2M060DS07
Reference: COX2M060DS
EMDN: W0105011703
EMDN description: COXIELLA BURNETII (Q FEVER)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details

+ENTICOX2M060009

NovaLisa® Coxiella burnetii (Q-Fever) Phase 2 IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICOX2M060009
Basic UDI-DI: B-+ENTICOX2M060009
Reference: COX2M0600
EMDN: W0105011703
EMDN description: COXIELLA BURNETII (Q FEVER)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details

+ENTICOX2G060DS01

NovaLisa® Coxiella burnetii (Q-Fever) Phase 2 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICOX2G060DS01
Basic UDI-DI: B-+ENTICOX2G060DS01
Reference: COX2G060DS
EMDN: W0105011703
EMDN description: COXIELLA BURNETII (Q FEVER)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details

+ENTICOX2G060003

NovaLisa® Coxiella burnetii (Q-Fever) Phase 2 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICOX2G060003
Basic UDI-DI: B-+ENTICOX2G060003
Reference: COX2G0600
EMDN: W0105011703
EMDN description: COXIELLA BURNETII (Q FEVER)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details

+ENTICOX1G060DS00

NovaLisa® Coxiella burnetii (Q-Fever) Phase 1 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICOX1G060DS00
Basic UDI-DI: B-+ENTICOX1G060DS00
Reference: COX1G060DS
EMDN: W0105011703
EMDN description: COXIELLA BURNETII (Q FEVER)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details

+ENTICOX1G060002

NovaLisa® Coxiella burnetii (Q-Fever) Phase 1 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICOX1G060002
Basic UDI-DI: B-+ENTICOX1G060002
Reference: COX1G0600
EMDN: W0105011703
EMDN description: COXIELLA BURNETII (Q FEVER)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details