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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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21.09.2026 21:01

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Active filter:Manufacturer SRN:DE-MF-000025020

420 device results listed.

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+ENTIPRES61340I

Mplex SARS-CoV-2+, Flu A, Flu B (C1)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPRES61340I
Basic UDI-DI: B-+ENTIPRES61340I
Reference: PRES6134
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 22:53

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+ENTIPRES61310F

Mplex SARS-CoV-2+, Flu A, Flu B (C1)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPRES61310F
Basic UDI-DI: B-+ENTIPRES61310F
Reference: PRES6131
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 22:53

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+ENTIZVM0790DS0C

NovaLisa® Zika Virus IgM μ-capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIZVM0790DS0C
Basic UDI-DI: B-+ENTIZVM0790DS0C
Reference: ZVM0790DS
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

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NovaLisa® Zika Virus IgM μ-capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIZVM07900E
Basic UDI-DI: B-+ENTIZVM07900E
Reference: ZVM0790
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

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+ENTIZVG0790DS06

NovaLisa® Zika Virus IgG capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIZVG0790DS06
Basic UDI-DI: B-+ENTIZVG0790DS06
Reference: ZVG0790DS
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

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NovaLisa® Zika Virus IgG capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIZVG079008
Basic UDI-DI: B-+ENTIZVG079008
Reference: ZVG0790
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

+ENTIYERG09900J

NovaLisa® Yersinia enterocolitica IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIYERG09900J
Basic UDI-DI: B-+ENTIYERG09900J
Reference: YERG0990
EMDN: W0105011706
EMDN description: YERSINIA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

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+ENTIYERA09900D

NovaLisa® Yersinia enterocolitica IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIYERA09900D
Basic UDI-DI: B-+ENTIYERA09900D
Reference: YERA0990
EMDN: W0105011706
EMDN description: YERSINIA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

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+ENTIVZVM0490DS0/

NovaLisa® Varicella-Zoster Virus (VZV) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIVZVM0490DS0/
Basic UDI-DI: B-+ENTIVZVM0490DS0/
Reference: VZVM0490DS
EMDN: W0105040903
EMDN description: VARICELLA ZOSTER VIRUS IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

+ENTIVZVM04900%

NovaLisa® Varicella-Zoster Virus (VZV) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIVZVM04900%
Basic UDI-DI: B-+ENTIVZVM04900%
Reference: VZVM0490
EMDN: W0105040903
EMDN description: VARICELLA ZOSTER VIRUS IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

+ENTIVZVG0490DS0Y

NovaLisa® Varicella-Zoster Virus (VZV) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIVZVG0490DS0Y
Basic UDI-DI: B-+ENTIVZVG0490DS0Y
Reference: VZVG0490DS
EMDN: W0105040902
EMDN description: VARICELLA ZOSTER VIRUS IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

+ENTIVZVG04900-

NovaLisa® Varicella-Zoster Virus (VZV) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIVZVG04900-
Basic UDI-DI: B-+ENTIVZVG04900-
Reference: VZVG0490
EMDN: W0105040902
EMDN description: VARICELLA ZOSTER VIRUS IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

+ENTIVZVA0490DS0S

NovaLisa® Varicella-Zoster Virus (VZV) IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIVZVA0490DS0S
Basic UDI-DI: B-+ENTIVZVA0490DS0S
Reference: VZVA0490DS
EMDN: W0105040999
EMDN description: VARICELLA ZOSTER VIRUS REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

+ENTIVZVA04900U

NovaLisa® Varicella-Zoster Virus (VZV) IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIVZVA04900U
Basic UDI-DI: B-+ENTIVZVA04900U
Reference: VZVA0490
EMDN: W0105040999
EMDN description: VARICELLA ZOSTER VIRUS REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

+ENTITOXM0460DS0Q

NovaLisa® Toxoplasma gondii IgM μ-capture

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTITOXM0460DS0Q
Basic UDI-DI: B-+ENTITOXM0460DS0Q
Reference: TOXM0460DS
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

+ENTITOXM04600S

NovaLisa® Toxoplasma gondii IgM μ-capture

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTITOXM04600S
Basic UDI-DI: B-+ENTITOXM04600S
Reference: TOXM0460
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

+ENTITOXG0460DS0K

NovaLisa® Toxoplasma gondii IgG

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTITOXG0460DS0K
Basic UDI-DI: B-+ENTITOXG0460DS0K
Reference: TOXG0460DS
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

+ENTITOXG04600M

NovaLisa® Toxoplasma gondii IgG

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTITOXG04600M
Basic UDI-DI: B-+ENTITOXG04600M
Reference: TOXG0460
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

+ENTITOXA0460DS0E

NovaLisa® Toxoplasma gondii IgA

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTITOXA0460DS0E
Basic UDI-DI: B-+ENTITOXA0460DS0E
Reference: TOXA0460DS
EMDN: W0105050199
EMDN description: TOXOPLASMA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

+ENTITOXA04600G

NovaLisa® Toxoplasma gondii IgA

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTITOXA04600G
Basic UDI-DI: B-+ENTITOXA04600G
Reference: TOXA0460
EMDN: W0105050199
EMDN description: TOXOPLASMA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details