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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

20.09.2026 11:56

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94 device results listed.

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Dengue IgG/IgM/NS1 Rapid Test Kit (Colloidal gold method)

Dengue IgG/IgM/NS1 Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349CR011G8
Basic UDI-DI: B-CNMF000054349CR011G8
Reference: CR011
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test Kit (Colloidal gold method)

Dengue IgG/IgM Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349CR010G6
Basic UDI-DI: B-CNMF000054349CR010G6
Reference: CR010
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors 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

ChainFor Dengue Virus Detection qPCR Kit

CFP95

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257925
Basic UDI-DI: B-08683548257925
Reference: CFP95
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:17

Manufacturer products View details

OnSite® Dengue Ag Rapid Test

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461105
Basic UDI-DI: 081011446R0063CDU
Reference: R0063C-25T
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

OnSite® Dengue Ag Rapid Test

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461112
Basic UDI-DI: 081011446R0063CDU
Reference: R0063C-20T
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

OnSite® Dengue Ag Rapid Test

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461129
Basic UDI-DI: 081011446R0063CDU
Reference: R0063C-10T
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Aria® Dengue Ag Rapid Test

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461136
Basic UDI-DI: 081011446R0063CDU
Reference: R0063C-30T-AR
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Aria® Dengue Ag Rapid Test

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461143
Basic UDI-DI: 081011446R0063CDU
Reference: R0063C-25T-AR
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Aria® Dengue Ag Rapid Test

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461150
Basic UDI-DI: 081011446R0063CDU
Reference: R0063C-20T-AR
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Aria® Dengue Ag Rapid Test

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461167
Basic UDI-DI: 081011446R0063CDU
Reference: R0063C-10T-AR
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

OnSite® Dengue Ag Rapid Test

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461600
Basic UDI-DI: 081011446R0063CDU
Reference: R0063C-50T
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Aria® Dengue Ag Rapid Test

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461617
Basic UDI-DI: 081011446R0063CDU
Reference: R0063C-50T-AR
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue virus NS1 Ag

Dengue virus NS1 Ag

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
Manufacturer SRN: IT-MF-000029123
UDI-DI: 08050616042262
Basic UDI-DI: B-08050616042262
Reference: DENS1AG.CE
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 19:10

Manufacturer products View details

Dengue IgG/lgM Antibody Rapid Test Cassette (Colloidal Gold)

1T/box,10T/box,20T/box,25T/box,40T/box,50T/box

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698401966
Basic UDI-DI: B-06977698401966
Reference: GKPD036
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Antigen Rapid Test Cassette (Colloidal Gold)

1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698401911
Basic UDI-DI: B-06977698401911
Reference: GKPD035
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Antigen (DEN NS1 Ag) Assay Reagent Kit (CMIA)

C2KC010

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753477861
Basic UDI-DI: B-06976753477861
Reference: C2KC010
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:01

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Rapid Test Device (whole blood/serum/plasma)

A260501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753473436
Basic UDI-DI: B-06976753473436
Reference: A260501D
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details