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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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+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-41990B

Herpes Simplex Virus 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-41990B
Basic UDI-DI: B-+ENTIEIA-41990B
Reference: EIA-4199
EMDN: W0105040310
EMDN description: HSV 2 IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

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+ENTIEIA-41980A

Herpes Simplex Virus 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-41980A
Basic UDI-DI: B-+ENTIEIA-41980A
Reference: EIA-4198
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

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+ENTIEIA-419709

Herpes Simplex Virus 1 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-419709
Basic UDI-DI: B-+ENTIEIA-419709
Reference: EIA-4197
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-419608

Herpes Simplex Virus 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-419608
Basic UDI-DI: B-+ENTIEIA-419608
Reference: EIA-4196
EMDN: W0105040306
EMDN description: HSV 1 IGG
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-38690E

Varicella-Zoster Virus (VZV) 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-38690E
Basic UDI-DI: B-+ENTIEIA-38690E
Reference: EIA-3869
EMDN: W0105040903
EMDN description: VARICELLA ZOSTER VIRUS IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-38680D

Varicella-Zoster Virus (VZV) 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-38680D
Basic UDI-DI: B-+ENTIEIA-38680D
Reference: EIA-3868
EMDN: W0105040902
EMDN description: VARICELLA ZOSTER VIRUS IGG
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-38670C

Varicella-Zoster Virus (VZV) IgA ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-38670C
Basic UDI-DI: B-+ENTIEIA-38670C
Reference: EIA-3867
EMDN: W0105040999
EMDN description: VARICELLA ZOSTER VIRUS REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-386409

Toxoplasma gondii IgM μ-capture 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-386409
Basic UDI-DI: B-+ENTIEIA-386409
Reference: EIA-3864
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-386308

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-386308
Basic UDI-DI: B-+ENTIEIA-386308
Reference: EIA-3863
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-386207

Toxoplasma gondii 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-386207
Basic UDI-DI: B-+ENTIEIA-386207
Reference: EIA-3862
EMDN: W0105050199
EMDN description: TOXOPLASMA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-38580C

Rubella Virus IgM μ-capture 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-38580C
Basic UDI-DI: B-+ENTIEIA-38580C
Reference: EIA-3858
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-38570B

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-38570B
Basic UDI-DI: B-+ENTIEIA-38570B
Reference: EIA-3857
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-385206

Parvovirus B19 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-385206
Basic UDI-DI: B-+ENTIEIA-385206
Reference: EIA-3852
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-385105

Parvovirus B19 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-385105
Basic UDI-DI: B-+ENTIEIA-385105
Reference: EIA-3851
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-384508

Measles Virus 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-384508
Basic UDI-DI: B-+ENTIEIA-384508
Reference: EIA-3845
EMDN: W0105040703
EMDN description: MEASLES VIRUS IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details