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223 device results listed.

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POCBio Dengue NS1 Antigen Rapid Test

LATT01-C50

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nexlab Co., Ltd.
Manufacturer SRN: CN-MF-000047094
UDI-DI: 06974912093792
Basic UDI-DI: B-06974912093792
Reference: LATT01-C50
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

POCBio Dengue NS1 Antigen Rapid Test

LATT01-C25

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nexlab Co., Ltd.
Manufacturer SRN: CN-MF-000047094
UDI-DI: 06974912093785
Basic UDI-DI: B-06974912093785
Reference: LATT01-C25
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM FIA Kit

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892428
Basic UDI-DI: B-06974674892428
Reference: 18-02-0072
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:14

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Ag FIA Kit

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892411
Basic UDI-DI: B-06974674892411
Reference: 18-02-0071
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:14

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method)

100 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674891391
Basic UDI-DI: B-06974674891391
Reference: 18-02-0025
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:11

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method)

50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674891384
Basic UDI-DI: B-06974674891384
Reference: 18-02-0024
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:11

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method)

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674891377
Basic UDI-DI: B-06974674891377
Reference: 18-02-0023
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:11

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001898
Basic UDI-DI: B-06974521001898
Reference: SUPG020025-1
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001881
Basic UDI-DI: B-06974521001881
Reference: SUPG020025
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Anti-Dengue IgG/IgM Tri-line Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001836
Basic UDI-DI: B-06974521001836
Reference: SUPG019025-1
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Anti-Dengue IgG/IgM Tri-line Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001829
Basic UDI-DI: B-06974521001829
Reference: SUPG019025
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX DENGUE Ab BSS

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678592985
Basic UDI-DI: B-03532678592985
Reference: SW40016
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX DENGUE Ag BSS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678592978
Basic UDI-DI: B-03532678592978
Reference: SW40015
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX DENGUE COMBO BSS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678592961
Basic UDI-DI: B-03532678592961
Reference: SW40014
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

Artron Dengue NS1 Antigen Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561604
Basic UDI-DI: B-00628347561604
Reference: A03-22-222
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Netherlands
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-000041242DEN003-256L

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041242
UDI-DI: D-000041242DEN003-256L
Basic UDI-DI: B-000041242DEN003-256L
Reference: DEN003-25
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-000041242DEN003-056E

5 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041242
UDI-DI: D-000041242DEN003-056E
Basic UDI-DI: B-000041242DEN003-056E
Reference: DEN003-05
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-000041242DEN003-0166

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041242
UDI-DI: D-000041242DEN003-0166
Basic UDI-DI: B-000041242DEN003-0166
Reference: DEN003-01
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IDE-A402-01; IDE-A402-05; IDE-A402-20; IDE-A402-25; IDE-A402-40

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412613991
Basic UDI-DI: 697241261IDE-A402EJ
Reference: IDE-A402-25
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

05902643958630

Dengue Ab/Ag kasetki 20 szt.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958630
Basic UDI-DI: 59026439BRT355JV
Reference: 1-355-K020
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details