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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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+ENTIHEVM078009

NovaLisa® Hepatitis E Virus (HEV) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIHEVM078009
Basic UDI-DI: B-+ENTIHEVM078009
Reference: HEVM0780
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIHEVG078003

NovaLisa® Hepatitis E Virus (HEV) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIHEVG078003
Basic UDI-DI: B-+ENTIHEVG078003
Reference: HEVG0780
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIHELM02200V

NovaLisa® Helicobacter pylori IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIHELM02200V
Basic UDI-DI: B-+ENTIHELM02200V
Reference: HELM0220
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIHELG0220DS0N

NovaLisa® 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: +ENTIHELG0220DS0N
Basic UDI-DI: B-+ENTIHELG0220DS0N
Reference: HELG0220DS
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIHELG02200P

NovaLisa® 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: +ENTIHELG02200P
Basic UDI-DI: B-+ENTIHELG02200P
Reference: HELG0220
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIHANM06700_

NovaLisa® Hantavirus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIHANM06700_
Basic UDI-DI: B-+ENTIHANM06700_
Reference: HANM0670
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIHANG06700W

NovaLisa® Hantavirus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIHANG06700W
Basic UDI-DI: B-+ENTIHANG06700W
Reference: HANG0670
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIFT4105007

NovaLisa® Free T4

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIFT4105007
Basic UDI-DI: B-+ENTIFT4105007
Reference: FT41050
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIFIL0760DS0I

NovaLisa® Filariasis

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIFIL0760DS0I
Basic UDI-DI: B-+ENTIFIL0760DS0I
Reference: FIL0760DS
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIFIL07600K

NovaLisa® Filariasis

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIFIL07600K
Basic UDI-DI: B-+ENTIFIL07600K
Reference: FIL0760
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIENTG0140DS0_

NovaLisa® Entamoeba histolytica IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIENTG0140DS0_
Basic UDI-DI: B-+ENTIENTG0140DS0_
Reference: ENTG0140DS
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIENTG01400/

NovaLisa® Entamoeba histolytica IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIENTG01400/
Basic UDI-DI: B-+ENTIENTG01400/
Reference: ENTG0140
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-59840E

Zika Virus IgG capture ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-59840E
Basic UDI-DI: B-+ENTIEIA-59840E
Reference: EIA-5984
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-59660E

Avidity Rubella Virus IgG ELISA

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: +ENTIEIA-59660E
Basic UDI-DI: B-+ENTIEIA-59660E
Reference: EIA-5966
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-59650D

Avidity Toxoplasma gondii IgG ELISA

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: +ENTIEIA-59650D
Basic UDI-DI: B-+ENTIEIA-59650D
Reference: EIA-5965
EMDN: W0105050104
EMDN description: TOXOPLASMA ANTIBODY IGG - AVIDITY
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-59640C

Avidity Cytomegalovirus (CMV) IgG ELISA

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: +ENTIEIA-59640C
Basic UDI-DI: B-+ENTIEIA-59640C
Reference: EIA-5964
EMDN: W0105040206
EMDN description: CMV IGG - AVIDITY
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-59080A

Zika Virus IgM μ-capture ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-59080A
Basic UDI-DI: B-+ENTIEIA-59080A
Reference: EIA-5908
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-581305

Chagas (Trypanosoma cruzi) 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-581305
Basic UDI-DI: B-+ENTIEIA-581305
Reference: EIA-5813
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-551100

Malaria ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-551100
Basic UDI-DI: B-+ENTIEIA-551100
Reference: EIA-5511
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

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