Ccts
by Coyote Bioscience Co., Ltd. 13 variants
Ref 6018020205-CE
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number6974767396018020208V 06974767390145 | Date30 Sep 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- COYOTE® CCTS™ Respiratory Swab Specimen Collection Kit
- Model / Reference
- 6018020205-CE
- Primary DI / UDI-DI
- 06974767390145
- Basic UDI-DI
- 6974767396018020208V
- Direct Marketing DI
- 06974767390145
- EMDN Code
- W05019099 Samples collection devices - other
- Device Class
- Class A
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CN-MF-000024155
- Authorised representative
- QbD RepS BV BE-AR-000000040
Other devices from Coyote Bioscience Co., Ltd.
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No