Identity
- Trade Name
- CCTS EUDAMED
- Device Name
- COYOTE® CCTS™ Respiratory Swab Specimen Collection Kit EUDAMED
- Model / Reference
- 6018020206-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974767390152 EUDAMED
- Basic UDI-DI
- 6974767396018020208V EUDAMED
- Direct Marketing DI
- 06974767390152 EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - 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
No
EUDAMED
New Device
No
EUDAMED
Ccts 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 | 6974767396018020208V | 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 2750e008-c3f8-4097-bdfd-903191cca236 61 fields · synced Jun 18, 2026