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223 device results listed.

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D-A006CT

INDICAID™Dengue Virus Rapid NS1 Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A006CT
Basic UDI-DI: B-A006CT
Reference: INDICAID™Dengue Virus Rapid NS1 Antigen 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

D-81649002CDGVZK01URTB

CDGVZK01-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CDGVZK01URTB
Basic UDI-DI: B-81649002CDGVZK01URTB
Reference: CDGVZK01-AHG4E
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CDGV01AD7RC

CDGV01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CDGV01AD7RC
Basic UDI-DI: B-81649002CDGV01AD7RC
Reference: CDGV01A-AHG4E
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test Device

P231106

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600286
Basic UDI-DI: B-16972698600286
Reference: P231106
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Rapid Test Device

P231104

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600279
Basic UDI-DI: B-16972698600279
Reference: P231104
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM/NS1 Combo Rapid Test Device

P231105

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600163
Basic UDI-DI: B-16972698600163
Reference: P231105
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Dengue IgG/IgM/ NS1 Combo Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763198
Basic UDI-DI: B-15065023763198
Reference: TV10020
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Dengue NS1 Ag Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763181
Basic UDI-DI: B-15065023763181
Reference: TV10019
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Dengue IgG/IgM Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763174
Basic UDI-DI: B-15065023763174
Reference: TV10018
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

SOFTEC Dengue NS1 Rapid Test Kit

Dengue NS1 Rapid Test Kit

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616732
Basic UDI-DI: B-08697962616732
Reference: SFDNNS1
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:22

Manufacturer products View details

SOFTEC Dengue NS1/IgG/IgM Combo Rapid Test Kit

SFDNCB40

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616725
Basic UDI-DI: B-08697962616725
Reference: SFDNCB
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:22

Manufacturer products View details

08693285187706

Dengue NS1 Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187706
Basic UDI-DI: B-08693285187706
Reference: TIDG03001
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:33

Manufacturer products View details

08693285187690

Dengue NS1, IgG/IgM Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187690
Basic UDI-DI: B-08693285187690
Reference: TIDG02001
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:33

Manufacturer products View details

08693285187683

Dengue IgG/IgM Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187683
Basic UDI-DI: B-08693285187683
Reference: TIDG01001
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:33

Manufacturer products View details

08693285187348

Dengue NS1 Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187348
Basic UDI-DI: B-08693285187348
Reference: TIDG03010
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:32

Manufacturer products View details

08693285187331

Dengue NS1, IgG/IgM Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187331
Basic UDI-DI: B-08693285187331
Reference: TIDG02010
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:32

Manufacturer products View details

08693285187324

Dengue IgG/IgM Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187324
Basic UDI-DI: B-08693285187324
Reference: TIDG01010
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:32

Manufacturer products View details

08693285187089

Dengue NS1 Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187089
Basic UDI-DI: B-08693285187089
Reference: TIDG03
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:32

Manufacturer products View details

08693285187072

Dengue NS1, IgG/IgM Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187072
Basic UDI-DI: B-08693285187072
Reference: TIDG02
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:32

Manufacturer products View details

08693285187065

Dengue IgG/IgM Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187065
Basic UDI-DI: B-08693285187065
Reference: TIDG01
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:32

Manufacturer products View details