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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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22.09.2026 04:45

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+ENTIMYCG035002

NovaLisa® Mycoplasma pneumoniae IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIMYCG035002
Basic UDI-DI: B-+ENTIMYCG035002
Reference: MYCG0350
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

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+ENTIMYCA0350DS0.

NovaLisa® Mycoplasma pneumoniae IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIMYCA0350DS0.
Basic UDI-DI: B-+ENTIMYCA0350DS0.
Reference: MYCA0350DS
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

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+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

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+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

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+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

+ENTILEGM0650DS0Z

NovaLisa® Legionella pneumophila IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEGM0650DS0Z
Basic UDI-DI: B-+ENTILEGM0650DS0Z
Reference: LEGM0650DS
EMDN: W0105010502
EMDN description: LEGIONELLA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

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+ENTILEGM06500.

NovaLisa® Legionella pneumophila IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEGM06500.
Basic UDI-DI: B-+ENTILEGM06500.
Reference: LEGM0650
EMDN: W0105010502
EMDN description: LEGIONELLA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

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+ENTILEGG0650DS0T

NovaLisa® Legionella pneumophila IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEGG0650DS0T
Basic UDI-DI: B-+ENTILEGG0650DS0T
Reference: LEGG0650DS
EMDN: W0105010502
EMDN description: LEGIONELLA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTILEGG06500V

NovaLisa® Legionella pneumophila IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEGG06500V
Basic UDI-DI: B-+ENTILEGG06500V
Reference: LEGG0650
EMDN: W0105010502
EMDN description: LEGIONELLA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

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

+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

+ENTIEIA-41600%

Chlamydia pneumoniae IgA 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-41600%
Basic UDI-DI: B-+ENTIEIA-41600%
Reference: EIA-4160
EMDN: W0105010114
EMDN description: CHLAMYDIA PNEUMONIAE ANTIBODY IGA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-391304

Chlamydia pneumoniae IgM 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-391304
Basic UDI-DI: B-+ENTIEIA-391304
Reference: EIA-3913
EMDN: W0105010116
EMDN description: CHLAMYDIA PNEUMONIAE ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-391203

Chlamydia pneumoniae 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-391203
Basic UDI-DI: B-+ENTIEIA-391203
Reference: EIA-3912
EMDN: W0105010115
EMDN description: CHLAMYDIA PNEUMONAIE ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-381101

Chlamydia trachomatis IgM 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-381101
Basic UDI-DI: B-+ENTIEIA-381101
Reference: EIA-3811
EMDN: W0105010111
EMDN description: CHLAMYDIA TRACHOMATIS ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIEIA-381000

Chlamydia trachomatis 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-381000
Basic UDI-DI: B-+ENTIEIA-381000
Reference: EIA-3810
EMDN: W0105010110
EMDN description: CHLAMYDIA TRACHOMATIS ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details