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FlashDetect
EUDAMEDClass IVD General (EU MDR)
Ref 6018027105-CERef 6018022502-CERef 6018031805-CERef 6018022507-CERef 6018012505-CERef 6018026305-CERef 6018032105-CERef 08020006Model FlashDetect NanoRef 6018031802-CERef 6018018605-CERef 6018027102-CERef 6018033002-CERef 6018032102-CERef 6018021905-CERef 6018012205-CERef 6018020405-CERef 6018033402-CE
Identity
- Trade Name
- FlashDetect EUDAMED
- Device Name
- FlashDetect™ Lyocart GBS Assay EUDAMEDFlashDetect™ LyocartE Monkeypox Virus Assay EUDAMEDFlashDetect™ LyocartE SARS-CoV-2&FluA&FluB&RSV Assay EUDAMEDFlashDetect™ LyocartE MG&TV&MH Assay EUDAMEDFlashDetect™ LyocartE RSV&MP&ADV Assay EUDAMEDFlashDetect™ LyocartE HSV-1&HSV-2&VZV Assay EUDAMEDFlashDetect™ Nano System EUDAMEDFlashDetect™ LyocartE Enterovirus 71 Assay EUDAMEDFlashDetect™ LyocartE Norovirus GI/GII Assay EUDAMEDFlashDetect™ Lyocart Strep A Assay EUDAMEDFlashDetect™ LyocartE HSV-1&HSV-2 Assay EUDAMEDFlashDetect™ LyocartE MRSA&SA Assay EUDAMEDFlashDetect™ LyocartE Dengue virus type III/IV Assay EUDAMED
- Model / Reference
- 6018027105-CE EUDAMED6018022502-CE EUDAMED6018031805-CE EUDAMED6018022507-CE EUDAMED6018012505-CE EUDAMED6018026305-CE EUDAMED6018032105-CE EUDAMEDFlashDetect Nano EUDAMED08020006 EUDAMED6018031802-CE EUDAMED6018018605-CE EUDAMED6018027102-CE EUDAMED6018033002-CE EUDAMED6018032102-CE EUDAMED6018021905-CE EUDAMED6018012205-CE EUDAMED6018020405-CE EUDAMED6018033402-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974767392477 EUDAMED06974767391739 EUDAMED06974767391883 EUDAMED06974767391913 EUDAMED06974767391517 EUDAMED06974767392248 EUDAMED06974767391845 EUDAMED06977739174132 EUDAMED06974767391975 EUDAMED06974767392057 EUDAMED06974767392453 EUDAMED06974767391944 EUDAMED06974767392033 EUDAMED06974767392439 EUDAMED06974767390756 EUDAMED06974767391548 EUDAMED06974767392071 EUDAMED
- Basic UDI-DI
- B-06974767392477 EUDAMEDB-06974767391739 EUDAMEDB-06974767391883 EUDAMEDB-06974767391913 EUDAMEDB-06974767391517 EUDAMEDB-06974767392248 EUDAMEDB-06974767391845 EUDAMED697773917080200063L EUDAMEDB-06974767391975 EUDAMEDB-06974767392057 EUDAMEDB-06974767392453 EUDAMEDB-06974767391944 EUDAMEDB-06974767392033 EUDAMEDB-06974767392439 EUDAMEDB-06974767390756 EUDAMEDB-06974767391548 EUDAMEDB-06974767392071 EUDAMED
- Direct Marketing DI
- 06977739174132 EUDAMED
- EMDN Code
- W0105011104 STREP. B DETECTION BY NA REAGENTS EUDAMEDW0105040532 MONKEYPOX VIRUS / MPOX - NA REAGENT EUDAMEDW0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMEDW0105010803 MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS EUDAMEDW0105040399 HSV REAGENTS - OTHER EUDAMEDW02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMEDW0105040502 ENTEROVIRUS - NA REAGENTS EUDAMEDW0105040516 NOROVIRUS - NA REAGENTS EUDAMEDW0105011103 STREP. A DETECTION BY NA REAGENTS EUDAMEDW0105040311 HSV - NA REAGENTS EUDAMEDW0105011203 STAPHYLOCOCCAL DETECTION BY NA REAGENTS EUDAMEDW0105040511 DENGUE VIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMED
- Market of Registration
- Italy EUDAMEDSweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
New Device
No
EUDAMED
FlashDetect by Coyote Bioscience Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06974767392477 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06974767392477 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Coyote Bioscience Co., Ltd.
- EUDAMED SRN
- CN-MF-000024155
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (17)
- EUDAMED 315405f1-0b67-4cd4-94b8-de6338a56c76 61 fields · synced Aug 4, 2026
- EUDAMED 76e8d4f0-93ae-4843-8269-7fccb09da820 61 fields · synced May 16, 2026
- EUDAMED e264fa06-3b55-4220-969d-4c50342cc561 61 fields · synced May 16, 2026
- EUDAMED 819b007f-10ae-4189-82e0-dd078116e3a7 61 fields · synced May 16, 2026
- EUDAMED b2e361b4-fe81-4e80-b32b-fd088c33b813 61 fields · synced May 16, 2026
- EUDAMED 5bc11275-50ee-4423-95b2-0e5945cc1556 61 fields · synced May 17, 2026
- EUDAMED f9a4e046-ef3d-4b0d-9867-ee6223d7aa17 61 fields · synced May 17, 2026
- EUDAMED 50ed83b8-aaa2-4cf3-9fb9-97568c07d8d0 61 fields · synced May 17, 2026
- EUDAMED 42907cd6-4814-443d-8392-c27497c174c8 61 fields · synced May 17, 2026
- EUDAMED 51ad3309-7024-43a1-b0db-955c815dc358 61 fields · synced May 17, 2026
- EUDAMED dc489dd2-791a-4acb-9792-ca757ba8192e 61 fields · synced May 18, 2026
- EUDAMED 5657a8ed-7107-436a-abf4-0cdd72091db3 61 fields · synced May 18, 2026
- EUDAMED 1979b626-4d1e-450a-8a52-10f553d59091 61 fields · synced May 18, 2026
- EUDAMED 9c25c533-b357-4f20-a75d-bdf65cd04857 61 fields · synced May 18, 2026
- EUDAMED d07fb505-ab3a-4f78-bbf6-b1607ddd4346 61 fields · synced May 18, 2026
- EUDAMED 8611277f-236f-4f18-9ce5-0a6f9c7c5f2e 61 fields · synced May 19, 2026
- EUDAMED cb9c45e9-7346-4923-a038-807e390c05c0 61 fields · synced May 19, 2026