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94 device results listed.

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Dengue Ab and Ag Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

IDEC-5023

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750556
Basic UDI-DI: B-06974785750556
Reference: IDEC-5023
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

+ENTIRE586810M

Dengue Virus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE586810M
Basic UDI-DI: B-+ENTIRE586810M
Reference: RE58681
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIRE586710L

Dengue Virus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE586710L
Basic UDI-DI: B-+ENTIRE586710L
Reference: RE58671
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIRE585810L

Dengue Virus IgM µ-capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE585810L
Basic UDI-DI: B-+ENTIRE585810L
Reference: RE58581
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTINS1D40200O

NovaLisa® Dengue Virus NS1 Antigen

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTINS1D40200O
Basic UDI-DI: B-+ENTINS1D40200O
Reference: NS1D4020
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIDVM0640DS0R

NovaLisa® Dengue Virus IgM µ-capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDVM0640DS0R
Basic UDI-DI: B-+ENTIDVM0640DS0R
Reference: DVM0640DS
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIDVM06400T

NovaLisa® Dengue Virus IgM µ-capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDVM06400T
Basic UDI-DI: B-+ENTIDVM06400T
Reference: DVM0640
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIDENG0120DS0K

NovaLisa® Dengue Virus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDENG0120DS0K
Basic UDI-DI: B-+ENTIDENG0120DS0K
Reference: DENG0120DS
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTIDENG01200M

NovaLisa® Dengue Virus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDENG01200M
Basic UDI-DI: B-+ENTIDENG01200M
Reference: DENG0120
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTIDENM0120DS0Q

NovaLisa® Dengue Virus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDENM0120DS0Q
Basic UDI-DI: B-+ENTIDENM0120DS0Q
Reference: DENM0120DS
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTIDENM01200S

NovaLisa® Dengue Virus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDENM01200S
Basic UDI-DI: B-+ENTIDENM01200S
Reference: DENM0120
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

OnSite® Dengue Ag Rapid Test

R0063C

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

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114460023
Basic UDI-DI: 081011446R0063CDU
Reference: R0063C
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Denmark
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-554E

Dengue IgG & IgM Antibody Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-554E
Basic UDI-DI: B-TD-HNKX-CED-554E
Reference: /
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-5044

Dengue Virus Antigen Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-5044
Basic UDI-DI: B-TD-HNKX-CED-5044
Reference: /
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM 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-GKPD156XR
Basic UDI-DI: B-GKPD156XR
Reference: GKPD156
EMDN: W0105040611
EMDN description: DENGUE VIRUS
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 NS1+IgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCDEN-425a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCDEN-425aUL
Basic UDI-DI: B-GCDEN-425aUL
Reference: GCDEN-425a
EMDN: W0105040611
EMDN description: DENGUE VIRUS
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

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

GCDEN(ab)-402e

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCDEN(ab)-402eQG
Basic UDI-DI: B-GCDEN(ab)-402eQG
Reference: GCDEN(ab)-402e
EMDN: W0105040611
EMDN description: DENGUE VIRUS
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 testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCDEN(ab)-402cQC
Basic UDI-DI: B-GCDEN(ab)-402cQC
Reference: GCDEN(ab)-402c
EMDN: W0105040611
EMDN description: DENGUE VIRUS
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 testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCDEN(NS)-402dAS
Basic UDI-DI: B-GCDEN(NS)-402dAS
Reference: GCDEN(NS)-402d
EMDN: W0105040611
EMDN description: DENGUE VIRUS
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 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-CNMF000054349CR022GD
Basic UDI-DI: B-CNMF000054349CR022GD
Reference: CR022
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