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209 device results listed.

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Dengue IgG/IgM Rapid Test Kit(Whole Blood/serum/plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646DEN000EQRN
Basic UDI-DI: B-697424646DEN000EQRN
Reference: DEN-3022
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Rapid Test Kit(Whole Blood/serum/plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CTNI000U8JT
Basic UDI-DI: B-697424646CTNI000U8JT
Reference: CTNI-4012
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

DEG-P21（25PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712009349C
Basic UDI-DI: B-69717712009349C
Reference: DEG-W21（25PCS）
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Antigen Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5N23C1ZC
Basic UDI-DI: B-5N23C1ZC
Reference: 5N23C1-25-EU, 5N23C1-50-EU
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Combo Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5N04C1Z3
Basic UDI-DI: B-5N04C1Z3
Reference: 5N04C1-25-EU, 5N04C1-50-EU
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

NADAL® Dengue NS1 Ag+IgG/IgM Test

Dengue NS1 Ag+IgG/IgM Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-532919N-105A
Basic UDI-DI: B-nvm-532919N-105A
Reference: 532919N-10
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

Manufacturer products View details

Bio·Firm

WI-MICR-C43A-25

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-MICR-C43A-25A3
Basic UDI-DI: B-WI-MICR-C43A-25A3
Reference: WI-MICR-C43A-25
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 13:31

Manufacturer products Authorised representative products Authorised representative actors View details

Bio·Firm

WI-MICR-C43A-10

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-MICR-C43A-109N
Basic UDI-DI: B-WI-MICR-C43A-109N
Reference: WI-MICR-C43A-10
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 13:31

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Ag Rapid Test

VIDEg-402

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIDEg-402NX
Basic UDI-DI: B-VIDEg-402NX
Reference: VIDEg-402
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test

VIDEb-402

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIDEb-402M8
Basic UDI-DI: B-VIDEb-402M8
Reference: VIDEb-402
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM and NS1 Combo Rapid Test

VIDE-426

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIDE-426KC
Basic UDI-DI: B-VIDE-426KC
Reference: VIDE-426
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit

SC20301W-25T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC20301W-25TWK
Basic UDI-DI: B-SC20301W-25TWK
Reference: SC20301W-25T
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:39

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit

SC20301W-50T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC20301W-50TWK
Basic UDI-DI: B-SC20301W-50TWK
Reference: SC20301W-50T
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:39

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit

SC20301W-20T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC20301W-20TW4
Basic UDI-DI: B-SC20301W-20TW4
Reference: SC20301W-20T
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:39

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit

SC20301W-1T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC20301W-1T26
Basic UDI-DI: B-SC20301W-1T26
Reference: SC20301W-1T
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:39

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test Kit

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC20201W-50TVY
Basic UDI-DI: B-SC20201W-50TVY
Reference: SC20201W-50T
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test Kit

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC20201W-25TVY
Basic UDI-DI: B-SC20201W-25TVY
Reference: SC20201W-25T
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test Kit

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC20201W-20TVH
Basic UDI-DI: B-SC20201W-20TVH
Reference: SC20201W-20T
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test Kit

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC20201W-1TZJ
Basic UDI-DI: B-SC20201W-1TZJ
Reference: SC20201W-1T
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Ag Rapid Test Kit

SC20101W-50T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC20101W-50TVD
Basic UDI-DI: B-SC20101W-50TVD
Reference: SC20101W-50T
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details