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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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+ENTIDENG0120DS0K

NovaLisa® Dengue Virus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDENG0120DS0K
Basic UDI-DI: B-+ENTIDENG0120DS0K
Reference: DENG0120DS
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTIDENG01200M

NovaLisa® Dengue Virus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDENG01200M
Basic UDI-DI: B-+ENTIDENG01200M
Reference: DENG0120
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

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+ENTIDENM0120DS0Q

NovaLisa® Dengue Virus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDENM0120DS0Q
Basic UDI-DI: B-+ENTIDENM0120DS0Q
Reference: DENM0120DS
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTIDENM01200S

NovaLisa® Dengue Virus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDENM01200S
Basic UDI-DI: B-+ENTIDENM01200S
Reference: DENM0120
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTICHIM0590DS0Y

NovaLisa® Chikungunya 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: +ENTICHIM0590DS0Y
Basic UDI-DI: B-+ENTICHIM0590DS0Y
Reference: CHIM0590DS
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:09

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+ENTICHIM05900-

NovaLisa® Chikungunya 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: +ENTICHIM05900-
Basic UDI-DI: B-+ENTICHIM05900-
Reference: CHIM0590
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:09

Manufacturer products View details

+ENTICHIG0590DS0S

NovaLisa® Chikungunya 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: +ENTICHIG0590DS0S
Basic UDI-DI: B-+ENTICHIG0590DS0S
Reference: CHIG0590DS
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:09

Manufacturer products View details

+ENTICHIG05900U

NovaLisa® Chikungunya 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: +ENTICHIG05900U
Basic UDI-DI: B-+ENTICHIG05900U
Reference: CHIG0590
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:09

Manufacturer products View details

+ENTI301140770J

TBE/FSME IgG plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140770J
Basic UDI-DI: B-+ENTI301140770J
Reference: 30114077
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

+ENTI301140680J

Parainfluenza Virus 1, 2, 3 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140680J
Basic UDI-DI: B-+ENTI301140680J
Reference: 30114068
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

+ENTI301140670I

Parainfluenza Virus 1, 2, 3 IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140670I
Basic UDI-DI: B-+ENTI301140670I
Reference: 30114067
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

+ENTI301140540E

Influenza Virus B IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140540E
Basic UDI-DI: B-+ENTI301140540E
Reference: 30114054
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

+ENTI301140530D

Influenza Virus B IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140530D
Basic UDI-DI: B-+ENTI301140530D
Reference: 30114053
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

+ENTI301140520C

Influenza Virus B IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140520C
Basic UDI-DI: B-+ENTI301140520C
Reference: 30114052
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

+ENTI301140510B

Influenza Virus A IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140510B
Basic UDI-DI: B-+ENTI301140510B
Reference: 30114051
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

+ENTI301140500A

Influenza Virus A IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140500A
Basic UDI-DI: B-+ENTI301140500A
Reference: 30114050
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

+ENTI301140490I

Influenza Virus A IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140490I
Basic UDI-DI: B-+ENTI301140490I
Reference: 30114049
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

+ENTI301140430C

Hantavirus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140430C
Basic UDI-DI: B-+ENTI301140430C
Reference: 30114043
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

+ENTI301140420B

Hantavirus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140420B
Basic UDI-DI: B-+ENTI301140420B
Reference: 30114042
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

+ENTI301134410D

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: +ENTI301134410D
Basic UDI-DI: B-+ENTI301134410D
Reference: 30113441
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details