Identity
- Trade Name
- FlashDetect EUDAMED
- Device Name
- FlashDetect Mixer EUDAMED
- Model / Reference
- FM-1 EUDAMED08020004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977739174118 EUDAMED
- Basic UDI-DI
- 697773917080200033E EUDAMED
- Direct Marketing DI
- 06977739174118 EUDAMED
- EMDN Code
- W02060199 ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Sweden 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
FlashDetect by Coyote Bioscience Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697773917080200033E | 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 5374960f-d9a2-4d11-861e-2cbd08c06b37 61 fields · synced Jun 18, 2026