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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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Accu-Tell® Influenza A+B Strip (Swab/ Nasal Aspirate)

Strip

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-A247V8
Basic UDI-DI: B-ABT-IDT-A247V8
Reference: ABT-IDT-A247
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Adenovirus Rapid Antigen Test

INDICAID™ Adenovirus Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A015CU
Basic UDI-DI: B-A015CU
Reference: INDICAID™ Adenovirus Rapid Antigen Test
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Dengue Virus Rapid Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A007CV
Basic UDI-DI: B-A007CV
Reference: INDICAID™ Dengue Virus Rapid Antibody Test
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™Dengue Virus Rapid NS1 Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A006CT
Basic UDI-DI: B-A006CT
Reference: INDICAID™Dengue Virus Rapid NS1 Antigen Test
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

SFTSV IgG/IgM Test Kit(Serum/plasma/whole blood)

SFT0082

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610450
Basic UDI-DI: B-86979834610450
Reference: SFT0082
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Zika Test Device (Serum/plasma/whole blood)

ZIK0237

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610290
Basic UDI-DI: B-86979834610290
Reference: Zika Test Device (Serum/plasma/whole blood)
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue Test Device(Serum/plasma/whole blood)

DEN0235

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610276
Basic UDI-DI: B-86979834610276
Reference: DEN0235
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya Test Device(Serum/plasma/whole blood)

CHI0236

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610191
Basic UDI-DI: B-86979834610191
Reference: CHI0236
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Test Kit (Serum/plasma/whole blood/rash exudate)

MPV0043

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610177
Basic UDI-DI: B-86979834610177
Reference: MPV0043
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Yellow Fever Antigen Test Kit(Serum/plasma/whole blood)

YF00137

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610023
Basic UDI-DI: B-86979834610023
Reference: YF00137
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM/NS1 Test Kit(Serum/plasma/whole blood)

DEN0038

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610016
Basic UDI-DI: B-86979834610016
Reference: DEN0038
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Simple Rotavirus / Stick Rotavirus

9.333.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779333Y7HJ
Basic UDI-DI: B-84295779333Y7HJ
Reference: 9.333.XXX.YY.ZZZ
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

Simple Norovirus / Stick Norovirus

9.041.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779041XPHT
Basic UDI-DI: B-84295779041XPHT
Reference: 9.041.XXX.YY.ZZZ
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

biotical Enterovirus Card (+PC +NC)

biotical Enterovirus Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Enterovirus +1 C. Negativo universal)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942146912
Basic UDI-DI: B-84365942146912
Reference: RTB25EVCN
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:03

Manufacturer products View details

biotical Enterovirus Card (+PC)

biotical Enterovirus Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Enterovirus)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942146844
Basic UDI-DI: B-84365942146844
Reference: RTB25EVC
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:03

Manufacturer products View details

biotical Enterovirus Card

biotical Enterovirus Card / 25 test rápidos con viales para muestra fecal (sin controles externos).

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942146776
Basic UDI-DI: B-84365942146776
Reference: RTB25EV
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:03

Manufacturer products View details

1 control positivo Norovirus Gen I (sin test rápido)

biotical Norovirus Gen I Positive control (1u) / 1 control positivo Norovirus Gen I (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942146462
Basic UDI-DI: B-84365942146462
Reference: CPRT01NG
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:03

Manufacturer products View details

biotical Norovirus Gen I + II Card (+PC +NC)

biotical Norovirus Gen I + II Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Norovirus Gen I + II +1 C. Negativo universal)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942146226
Basic UDI-DI: B-84365942146226
Reference: RTB25NVCN
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:03

Manufacturer products View details

biotical Norovirus Gen I + II Card (+PC)

biotical Norovirus Gen I + II Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Norovirus Gen I + II)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942146158
Basic UDI-DI: B-84365942146158
Reference: RTB25NVC
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:03

Manufacturer products View details

biotical Norovirus Gen I + II Card

biotical Norovirus Gen I + II Card / 25 test rápidos con viales para muestra fecal (sin controles externos).

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942146080
Basic UDI-DI: B-84365942146080
Reference: RTB25NV
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:03

Manufacturer products View details