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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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CL AIA-PACK Anti-SARS-CoV-2-SP-IgG ADJUSTER SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189216362
Basic UDI-DI: B-14560189216362
Reference: 0029272
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

CL AIA-PACK Anti-SARS-CoV-2-NP ADJUSTER SET

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189216294
Basic UDI-DI: B-14560189216294
Reference: 0029270
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

Reageana DOBRAVA-HANTAAN IgG EIA

Reagena DOBRAVA-HANTAAN IgG EIA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Reagena Oy
Manufacturer SRN: FI-MF-000002804
UDI-DI: D-114302LW
Basic UDI-DI: B-114302LW
Reference: 114302
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Slovenia
Authorised representative: -
Last updated: 11.07.2026 05:48

Manufacturer products View details

Reagena PUUMALA IgG EIA

Reagena PUUMALA IgG EIA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Reagena Oy
Manufacturer SRN: FI-MF-000002804
UDI-DI: D-114301LU
Basic UDI-DI: B-114301LU
Reference: 114301
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 05:48

Manufacturer products View details

Reagena DOBRAVA-HANTAAN IgM EIA

Reagena DOBRAVA-HANTAAN IgM EIA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKit

Manufacturer: Reagena Oy
Manufacturer SRN: FI-MF-000002804
UDI-DI: D-114202LR
Basic UDI-DI: B-114202LR
Reference: 114202
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Slovenia
Authorised representative: -
Last updated: 11.07.2026 05:48

Manufacturer products View details

Reagena PUUMALA IgM EIA

Reagena PUUMALA IgM EIA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Reagena Oy
Manufacturer SRN: FI-MF-000002804
UDI-DI: D-114201LP
Basic UDI-DI: B-114201LP
Reference: 114201
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 05:48

Manufacturer products View details

RapidKey COVID-19 Antigen Self Test (25)

301115

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013959550
Basic UDI-DI: B-08885013959550
Reference: 301115
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

RapidKey COVID-19 Antigen Self Test (7)

301114

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013959543
Basic UDI-DI: B-08885013959543
Reference: 301114
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

RapidKey COVID-19 Antigen Self Test (2)

301112

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013959529
Basic UDI-DI: B-08885013959529
Reference: 301112
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

RapidKey COVID-19 Antigen Self Test (5)

301113

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013959536
Basic UDI-DI: B-08885013959536
Reference: 301113
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

RapidKey COVID-19 Antigen Self Test (1)

301111

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013959512
Basic UDI-DI: B-08885013959512
Reference: 301111
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

CerTest CLIA Rotavirus Ag

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440259060
Basic UDI-DI: 84354402CLIGASTROB_RTV46
Reference: CL-RTV000
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: -
Authorised representative: -
Last updated: 10.07.2026 14:17

Manufacturer products View details

BioTracer™ Dengue Combo Rapid Card

BioTracer™ Dengue Combo Rapid Card

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317541181
Basic UDI-DI: B-08809317541181
Reference: 17311
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

BioTracer™ Dengue NS1 Ag Rapid Card

BioTracer™ Dengue NS1 Ag Rapid Card

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317541174
Basic UDI-DI: B-08809317541174
Reference: 17212
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

BioTracer™ Dengue IgG/IgM Rapid Card

BioTracer™ Dengue IgG/IgM Rapid Card

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317541167
Basic UDI-DI: B-08809317541167
Reference: 17112
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

FREND COVID-19 Ag

FREND COVID-19 Ag

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317541136
Basic UDI-DI: B-08809317541136
Reference: FRCOG-J 020P
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

FREND COVID-19 Ag

FREND COVID-19 Ag

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317541129
Basic UDI-DI: B-08809317541129
Reference: FRCOG 020P
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

FREND COVID-19 Ag

FREND COVID-19 Ag

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317541112
Basic UDI-DI: B-08809317541112
Reference: FRECOG-F 020P
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

FREND™ COVID-19 SP

FREND™ COVID-19 SP

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317541082
Basic UDI-DI: B-08809317541082
Reference: FRCOSW 020
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

FREND™ COVID-19 Neutralization Ab

FREND™ COVID-19 Neutralization Ab

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317541075
Basic UDI-DI: B-08809317541075
Reference: FRCON 020
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details