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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849368642
Basic UDI-DI: B-06974849368642
Reference: HWTS-OT200A
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)

48 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849368635
Basic UDI-DI: B-06974849368635
Reference: HWTS-OT200D
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)

16 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849368628
Basic UDI-DI: B-06974849368628
Reference: HWTS-OT200C
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795550658
Basic UDI-DI: B-06974795550658
Reference: 10201125B
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:46

Manufacturer products Authorised representative products Authorised representative actors View details

10 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795550641
Basic UDI-DI: B-06974795550641
Reference: 10201125A
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:46

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™ LyocartE CHIKV/YFV/DENV Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767393085
Basic UDI-DI: B-06974767393085
Reference: 6018038002-CE
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™ LyocartE RSV&MP&ADV Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392255
Basic UDI-DI: B-06974767392255
Reference: 6018026302-CE
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™ LyocartE RSV&MP&ADV Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392248
Basic UDI-DI: B-06974767392248
Reference: 6018026305-CE
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™ LyocartE Dengue virus type III/IV Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392071
Basic UDI-DI: B-06974767392071
Reference: 6018033402-CE
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™ LyocartE Dengue virus type I/II Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392064
Basic UDI-DI: B-06974767392064
Reference: 6018033202-CE
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™ LyocartE Enterovirus 71 Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392057
Basic UDI-DI: B-06974767392057
Reference: 6018018605-CE
EMDN: W0105040502
EMDN description: ENTEROVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™ LyocartE SARS-CoV-2&FluA&FluB&RSV Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767391975
Basic UDI-DI: B-06974767391975
Reference: 6018031802-CE
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™ LyocartE Norovirus GI/GII Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767391944
Basic UDI-DI: B-06974767391944
Reference: 6018033002-CE
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:41

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™ LyocartE SARS-CoV-2&FluA&FluB&RSV Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767391883
Basic UDI-DI: B-06974767391883
Reference: 6018031805-CE
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:41

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™ LyocartE Monkeypox Virus Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767391913
Basic UDI-DI: B-06974767391913
Reference: 6018022507-CE
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:41

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™ LyocartE Monkeypox Virus Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767391739
Basic UDI-DI: B-06974767391739
Reference: 6018022502-CE
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:41

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™LyocartE FluA&FluB&RSV Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767390763
Basic UDI-DI: B-06974767390763
Reference: 6018011605-CE
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:41

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™ LyocartE SARS-CoV-2 Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767390732
Basic UDI-DI: B-06974767390732
Reference: 6018007102-CE
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:41

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™ LyocartE SARS-CoV-2 Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767390633
Basic UDI-DI: B-06974767390633
Reference: 6018007105-CE
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:41

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect™ LyocartE FluA&FluB&RSV Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767390312
Basic UDI-DI: B-06974767390312
Reference: 6018011602-CE
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:41

Manufacturer products Authorised representative products Authorised representative actors View details