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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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Rubella Virus IgM μ-capture

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: +ENTIRE570910G
Basic UDI-DI: B-+ENTIRE570910G
Reference: RE57091
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:18

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Rubella Virus IgG

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: +ENTIRE570810F
Basic UDI-DI: B-+ENTIRE570810F
Reference: RE57081
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:18

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Cytomegalovirus (CMV) IgM

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: +ENTIRE570710E
Basic UDI-DI: B-+ENTIRE570710E
Reference: RE57071
EMDN: W0105040204
EMDN description: CMV IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:18

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Cytomegalovirus (CMV) IgG

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: +ENTIRE570610D
Basic UDI-DI: B-+ENTIRE570610D
Reference: RE57061
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:18

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Chlamydia pneumoniae IgM

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: +ENTIRE570510C
Basic UDI-DI: B-+ENTIRE570510C
Reference: RE57051
EMDN: W0105010116
EMDN description: CHLAMYDIA PNEUMONIAE ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:18

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Chlamydia pneumoniae IgG

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: +ENTIRE570410B
Basic UDI-DI: B-+ENTIRE570410B
Reference: RE57041
EMDN: W0105010115
EMDN description: CHLAMYDIA PNEUMONAIE ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:18

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Chlamydia pneumoniae 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: +ENTIRE570310A
Basic UDI-DI: B-+ENTIRE570310A
Reference: RE57031
EMDN: W0105010114
EMDN description: CHLAMYDIA PNEUMONIAE ANTIBODY IGA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:18

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Chlamydia trachomatis IgM

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: +ENTIRE5702109
Basic UDI-DI: B-+ENTIRE5702109
Reference: RE57021
EMDN: W0105010111
EMDN description: CHLAMYDIA TRACHOMATIS ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:18

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Chlamydia trachomatis IgG

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: +ENTIRE5701108
Basic UDI-DI: B-+ENTIRE5701108
Reference: RE57011
EMDN: W0105010110
EMDN description: CHLAMYDIA TRACHOMATIS ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:18

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Chlamydia trachomatis 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: +ENTIRE5700107
Basic UDI-DI: B-+ENTIRE5700107
Reference: RE57001
EMDN: W0105010109
EMDN description: CHLAMYDIA TRACHOMATIS ANTIBODY IGA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

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+ENTIPTICG044DS0G

NovaLisa® 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: +ENTIPTICG044DS0G
Basic UDI-DI: B-+ENTIPTICG044DS0G
Reference: PTICG044DS
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

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+ENTIPTICG0440I

NovaLisa® 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: +ENTIPTICG0440I
Basic UDI-DI: B-+ENTIPTICG0440I
Reference: PTICG044
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

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+ENTIPTETG043DS0S

NovaLisa® Clostridium tetani 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: +ENTIPTETG043DS0S
Basic UDI-DI: B-+ENTIPTETG043DS0S
Reference: PTETG043DS
EMDN: W0105011709
EMDN description: TETANUS (CLOSTRIDIUM T.)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIPTETG0430U

NovaLisa® Clostridium tetani 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: +ENTIPTETG0430U
Basic UDI-DI: B-+ENTIPTETG0430U
Reference: PTETG043
EMDN: W0105011709
EMDN description: TETANUS (CLOSTRIDIUM T.)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIPRSV61640_

RSV A, RSV B

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPRSV61640_
Basic UDI-DI: B-+ENTIPRSV61640_
Reference: PRSV6164
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIPRSV61610Z

RSV A, RSV B

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPRSV61610Z
Basic UDI-DI: B-+ENTIPRSV61610Z
Reference: PRSV6161
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIPRES61340I

Mplex SARS-CoV-2+, Flu A, Flu B (C1)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPRES61340I
Basic UDI-DI: B-+ENTIPRES61340I
Reference: PRES6134
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIPRES61310F

Mplex SARS-CoV-2+, Flu A, Flu B (C1)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPRES61310F
Basic UDI-DI: B-+ENTIPRES61310F
Reference: PRES6131
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIPHELG022DS05

NovaLisa® Helicobacter pylori IgG plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPHELG022DS05
Basic UDI-DI: B-+ENTIPHELG022DS05
Reference: PHELG022DS
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIPHELG02207

NovaLisa® Helicobacter pylori IgG plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPHELG02207
Basic UDI-DI: B-+ENTIPHELG02207
Reference: PHELG022
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details