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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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21.09.2026 20:20

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32 device results listed.

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RSV Rapid Test Device

K311416D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792053069
Basic UDI-DI: B-06971792053069
Reference: K311416D
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

Manufacturer products Authorised representative products Authorised representative actors View details

+ENTIRSVM0380DS0R

NovaLisa® Respiratory Syncytial Virus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRSVM0380DS0R
Basic UDI-DI: B-+ENTIRSVM0380DS0R
Reference: RSVM0380DS
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: -
Last updated: 04.07.2026 08:07

Manufacturer products View details

+ENTIRSVM03800T

NovaLisa® Respiratory Syncytial Virus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRSVM03800T
Basic UDI-DI: B-+ENTIRSVM03800T
Reference: RSVM0380
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: -
Last updated: 04.07.2026 08:07

Manufacturer products View details

+ENTIRSVG0380DS0L

NovaLisa® Respiratory Syncytial Virus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRSVG0380DS0L
Basic UDI-DI: B-+ENTIRSVG0380DS0L
Reference: RSVG0380DS
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: -
Last updated: 04.07.2026 08:07

Manufacturer products View details

+ENTIRSVG03800N

NovaLisa® Respiratory Syncytial Virus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRSVG03800N
Basic UDI-DI: B-+ENTIRSVG03800N
Reference: RSVG0380
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: -
Last updated: 04.07.2026 08:07

Manufacturer products View details

+ENTIRSVA0380DS0F

NovaLisa® Respiratory Syncytial Virus IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRSVA0380DS0F
Basic UDI-DI: B-+ENTIRSVA0380DS0F
Reference: RSVA0380DS
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: -
Last updated: 04.07.2026 08:07

Manufacturer products View details

+ENTIRSVA03800H

NovaLisa® Respiratory Syncytial Virus IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRSVA03800H
Basic UDI-DI: B-+ENTIRSVA03800H
Reference: RSVA0380
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: -
Last updated: 04.07.2026 08:07

Manufacturer products View details

+ENTI301140710D

Respiratory Syncytial Virus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140710D
Basic UDI-DI: B-+ENTI301140710D
Reference: 30114071
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: -
Last updated: 04.07.2026 08:07

Manufacturer products View details

+ENTI301140700C

Respiratory Syncytial Virus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140700C
Basic UDI-DI: B-+ENTI301140700C
Reference: 30114070
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: -
Last updated: 04.07.2026 08:07

Manufacturer products View details

+ENTI301140690K

Respiratory Syncytial Virus IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140690K
Basic UDI-DI: B-+ENTI301140690K
Reference: 30114069
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: -
Last updated: 04.07.2026 08:07

Manufacturer products View details

Respiratory Syncytial Virus Antigen Rapid Test

A46210120, A46210220

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804811112
Basic UDI-DI: 69528048A462100ZJ
Reference: A46210
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260204069
Basic UDI-DI: B-06933260204069
Reference: BT0101401
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details