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223 device results listed.

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Dengue Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IDEC-R425YM
Basic UDI-DI: B-IDEC-R425YM
Reference: IDEC-R425
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD155XP
Basic UDI-DI: B-GKPD155XP
Reference: GKPD155
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM/NS1 Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD115XB
Basic UDI-DI: B-GKPD115XB
Reference: GKPD115
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1+IgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCDEN-425a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCDEN-425aHGSA
Basic UDI-DI: B-GCDEN-425aHGSA
Reference: GCDEN-425a
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCDEN(ab)-402e

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCDEN(ab)-402eHGPF
Basic UDI-DI: B-GCDEN(ab)-402eHGPF
Reference: GCDEN(ab)-402e
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCDEN(ab)-402c

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCDEN(ab)-402cHGP5
Basic UDI-DI: B-GCDEN(ab)-402cHGP5
Reference: GCDEN(ab)-402c
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Ag Rapid Test Cassette(Whole Blood/Serum/Plasma)

GCDEN(NS)-402d

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCDEN(NS)-402dHG3E
Basic UDI-DI: B-GCDEN(NS)-402dHG3E
Reference: GCDEN(NS)-402d
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCDEN(NS)-402c

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCDEN(NS)-402cHG39
Basic UDI-DI: B-GCDEN(NS)-402cHG39
Reference: GCDEN(NS)-402c
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCDEN(NS)-402c

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCDEN(NS)-402cAQ
Basic UDI-DI: B-GCDEN(NS)-402cAQ
Reference: GCDEN(NS)-402c
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Flowflex

Flowflex Dengue NS1 Ag FIA Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-F131-10615-201RJ
Basic UDI-DI: B-F131-10615-201RJ
Reference: F131-10615-201
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

FIAflex

FIAflex Dengue NS1 Ag FIA Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-F131-10611-201Q6
Basic UDI-DI: B-F131-10611-201Q6
Reference: F131-10611-201
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM and NS1 Combo Rapid Test

DENC-435a

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-DENC-435aWK
Basic UDI-DI: B-DENC-435aWK
Reference: DENC-435a
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 13.07.2026 17:08

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test

DEN-422a

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-DEN-422a68
Basic UDI-DI: B-DEN-422a68
Reference: DEN-422a
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 13.07.2026 17:07

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Ag Rapid Test

DEN-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-DEN-402b5Y
Basic UDI-DI: B-DEN-402b5Y
Reference: DEN-402b
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 13.07.2026 17:07

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-DEAG-D02bTV
Basic UDI-DI: B-DEAG-D02bTV
Reference: DEAG-D02b
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:24

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM/NS1 Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-DEAB/DEAG-D35aTS
Basic UDI-DI: B-DEAB/DEAG-D35aTS
Reference: DEAB/DEAG-D35a
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:24

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-DEAB-D02aRS
Basic UDI-DI: B-DEAB-D02aRS
Reference: DEAB-D02a
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:24

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Dengue NS1 Antigen Cassette (Serum/Plasma)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-B274VJ
Basic UDI-DI: B-ABT-IDT-B274VJ
Reference: ABT-IDT-B274
EMDN: W0105099007
EMDN description: DENGUE - 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

Accu-Tell® Dengue IgG/IgM/NS1 Combo Cassette (Serum/Plasma)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-B259VN
Basic UDI-DI: B-ABT-IDT-B259VN
Reference: ABT-IDT-B259
EMDN: W0105099007
EMDN description: DENGUE - 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

D-A007CV

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