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01.08.2026 16:25

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58 device results listed.

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08885019710797

300186

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710797
Basic UDI-DI: B-08885019710797
Reference: 300186
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710773

300156

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710773
Basic UDI-DI: B-08885019710773
Reference: 300156
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710735

300185

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710735
Basic UDI-DI: B-08885019710735
Reference: 300185
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710742

300155

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710742
Basic UDI-DI: B-08885019710742
Reference: 300155
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA Dengue I-IV RT-PCR Test (4x8)

300050

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953121
Basic UDI-DI: B-08885013953121
Reference: 300050
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

08800204300164

RADI Dengue Virus Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300164
Basic UDI-DI: B-08800204300164
Reference: RV002
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx Dengue Virus Typing qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214025
Basic UDI-DI: B-08684387214025
Reference: IP202461-100
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 02:00

Manufacturer products View details

RevoDx Dengue Virus Typing qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214018
Basic UDI-DI: B-08684387214018
Reference: IP202461-25
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 02:00

Manufacturer products View details

RevoDx Dengue Virus Screening qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214001
Basic UDI-DI: B-08684387214001
Reference: IP202460-100
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:00

Manufacturer products View details

RevoDx Dengue Virus Screening qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213998
Basic UDI-DI: B-08684387213998
Reference: IP202460-25
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:00

Manufacturer products View details

LyoSens Dengue Virus Detection qPCR Kit

LYO66

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259851
Basic UDI-DI: B-08683548259851
Reference: LYO66
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:21

Manufacturer products View details

06978896416097

40 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896416097
Basic UDI-DI: B-06978896416097
Reference: W-IF2-DEN-40
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

06978896416080

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896416080
Basic UDI-DI: B-06978896416080
Reference: W-IF2-DEN-20
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

06975447582034

12 reactions/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN: CN-MF-000001552
UDI-DI: 06975447582034
Basic UDI-DI: B-06975447582034
Reference: 106-0043-01
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

VIUICK

Diagnostic Kit for Dengue Virus RNA (Real-Time PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Viuick Biotechnology Co.,LTD.
Manufacturer SRN: CN-MF-000017369
UDI-DI: 06975400320017
Basic UDI-DI: B-06975400320017
Reference: 48 Tests/Kit
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

VIUICK

Diagnostic Kit for Dengue Virus type I/II/III/IV RNA (Real-Time PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Viuick Biotechnology Co.,LTD.
Manufacturer SRN: CN-MF-000017369
UDI-DI: 06975400320000
Basic UDI-DI: B-06975400320000
Reference: 48 Tests/Kit
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

06974858560679

Dengue Virus Genotyping (I/II/III/IV) Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001080
UDI-DI: 06974858560679
Basic UDI-DI: B-06974858560679
Reference: P257H
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ LyocartE Dengue virus type III/IV Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392071
Basic UDI-DI: B-06974767392071
Reference: 6018033402-CE
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ LyocartE Dengue virus type I/II Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392064
Basic UDI-DI: B-06974767392064
Reference: 6018033202-CE
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

06974323011149

Real-Time PCR Detection Kit for Universal Dengue

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011149
Basic UDI-DI: B-06974323011149
Reference: A3801
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details