Identity
- Trade Name
- FlashDetect EUDAMED
- Device Name
- Real-Time PCR System (Flash20) EUDAMED
- Model / Reference
- Flash20 EUDAMED08020002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977739174200 EUDAMED
- Basic UDI-DI
- 697773917080200023C EUDAMED
- Direct Marketing DI
- 06977739174200 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
FlashDetect by Coyote Bioscience Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697773917080200023C | Class A | Active |
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Manufacturer
- Manufacturer
- Coyote Bioscience Co., Ltd.
- EUDAMED SRN
- CN-MF-000024155
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 4820bebb-6920-4d3b-8dd0-300c8a56106a 61 fields · synced Jun 18, 2026