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61 device results listed.

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FlashDetect

FlashDetect™ Lyocart DENV/CHIKV/ZIKV Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06977739170042
Basic UDI-DI: 697773917601803816A
Reference: 6018038002-CE, 6018038005-CE
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 09.10.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

COYOTE® CCTS™

COYOTE® CCTS™ Microbial Sample Collection Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767393214
Basic UDI-DI: 697773917601803245W
Reference: 6018032401-CE, 6018032402-CE, 6018032403-CE, 6018032404-CE, 6018032406-CE, 6018032407-CE
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 09.10.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

SPS-1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06977739170097
Basic UDI-DI: 697773917080200093S
Reference: 8020009
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 09.10.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ Lyocart Malaria Typing Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06977739170073
Basic UDI-DI: B-06977739170073
Reference: 6018045705-CE
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ Lyocart VRE Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06977739170066
Basic UDI-DI: B-06977739170066
Reference: 6018042705-CE
EMDN: W0102080319
EMDN description: VANCOMYCIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ Lyocart SARS-CoV-2&Flu A&Flu B&RSV 2.0 Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06977739170059
Basic UDI-DI: B-06977739170059
Reference: 6018045602-CE, 6018045605-CE，6018047602-CE, 6018047605-CE
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ Lyocart MTB&RIF Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06977739170035
Basic UDI-DI: B-06977739170035
Reference: 6018042805-CE
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ Lyocart C. difficile Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767393382
Basic UDI-DI: B-06974767393382
Reference: 6018022105-CE
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 15:15

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ LyocartE Chikungunya Virus Assay (For Serum, EDTA plasma and Urine)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767393139
Basic UDI-DI: B-06974767393139
Reference: 6018017717-CE
EMDN: W0105040525
EMDN description: CHIKUNGUNYA VIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 15:15

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ Lyocart Carba-R Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392880
Basic UDI-DI: B-06974767392880
Reference: 6018021005-CE
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 15:15

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetectTM SARS-CoV-2&Flu A&Flu B&RSV External Quality Control

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392484
Basic UDI-DI: B-06974767392484
Reference: 6018032001-CE, 6018032002-CE
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 15:14

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

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: 06977739177072
Basic UDI-DI: B-06977739177072
Reference: 6018040005-CE
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

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

FlashDetect™ LyocartE MTB Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767393061
Basic UDI-DI: B-06974767393061
Reference: 6018013905-CE
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY 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

FlashDetect™ LyocartE MTB Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767393054
Basic UDI-DI: B-06974767393054
Reference: 6018013902-CE
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY 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

FlashDetect™ Lyocart GBS Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392477
Basic UDI-DI: B-06974767392477
Reference: 6018027105-CE
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY 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

FlashDetect™ Lyocart GBS Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392453
Basic UDI-DI: B-06974767392453
Reference: 6018027102-CE
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY 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

FlashDetect™ Lyocart Strep A Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392439
Basic UDI-DI: B-06974767392439
Reference: 6018021905-CE
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY 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

FlashDetect™ Lyocart Strep A Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392422
Basic UDI-DI: B-06974767392422
Reference: 6018021902-CE
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY 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

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