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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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420 device results listed.

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+ENTI301140460F

Helicobacter pylori IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140460F
Basic UDI-DI: B-+ENTI301140460F
Reference: 30114046
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
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

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+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

+ENTI301136250H

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: +ENTI301136250H
Basic UDI-DI: B-+ENTI301136250H
Reference: 30113625
EMDN: W0105050199
EMDN description: TOXOPLASMA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

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+ENTI301136240G

Epstein-Barr Virus (VCA) IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301136240G
Basic UDI-DI: B-+ENTI301136240G
Reference: 30113624
EMDN: W010504040199
EMDN description: EBV ANTIBODIES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301136230F

Echinococcus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301136230F
Basic UDI-DI: B-+ENTI301136230F
Reference: 30113623
EMDN: W0105050204
EMDN description: ECHINOCOCCUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

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+ENTI301136220E

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: +ENTI301136220E
Basic UDI-DI: B-+ENTI301136220E
Reference: 30113622
EMDN: W0105011708
EMDN description: DIPHTERIA (CORYNEBACTERIUM D.)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301136210D

Corynebacterium diphtheriae toxin 5S IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301136210D
Basic UDI-DI: B-+ENTI301136210D
Reference: 30113621
EMDN: W0105011708
EMDN description: DIPHTERIA (CORYNEBACTERIUM D.)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301136200C

Corynebacterium diphtheriae toxin IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301136200C
Basic UDI-DI: B-+ENTI301136200C
Reference: 30113620
EMDN: W0105011708
EMDN description: DIPHTERIA (CORYNEBACTERIUM D.)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301136190K

Candida albicans IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301136190K
Basic UDI-DI: B-+ENTI301136190K
Reference: 30113619
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301136180J

Candida albicans IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301136180J
Basic UDI-DI: B-+ENTI301136180J
Reference: 30113618
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301136170I

Candida albicans IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301136170I
Basic UDI-DI: B-+ENTI301136170I
Reference: 30113617
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301134800G

Brucella IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301134800G
Basic UDI-DI: B-+ENTI301134800G
Reference: 30113480
EMDN: W0105011701
EMDN description: BRUCELLA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301134790O

Brucella IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301134790O
Basic UDI-DI: B-+ENTI301134790O
Reference: 30113479
EMDN: W0105011701
EMDN description: BRUCELLA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301134780N

Borrelia burgdorferi IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301134780N
Basic UDI-DI: B-+ENTI301134780N
Reference: 30113478
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301134770M

Borrelia burgdorferi IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301134770M
Basic UDI-DI: B-+ENTI301134770M
Reference: 30113477
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301134760L

Bordetella pertussis toxin (PT) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301134760L
Basic UDI-DI: B-+ENTI301134760L
Reference: 30113476
EMDN: W0105011707
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301134750K

Bordetella pertussis toxin (PT) IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301134750K
Basic UDI-DI: B-+ENTI301134750K
Reference: 30113475
EMDN: W0105011707
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301134740J

Bordetella pertussis IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301134740J
Basic UDI-DI: B-+ENTI301134740J
Reference: 30113474
EMDN: W0105011707
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301134730I

Bordetella pertussis IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301134730I
Basic UDI-DI: B-+ENTI301134730I
Reference: 30113473
EMDN: W0105011707
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details