Urine & Two Site Swab Sample Collection Kit (Rectal/Throat)
Ref T14000
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506075735T14000SZ 05060757350952 | Date7 Aug 2026 | 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- Withdrawn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/MDR Active
Specification
- Device Name
- Urine & Two Site Swab Sample Collection Kit (Rectal/Throat) (BOD)
- Model / Reference
- T14000
- Primary DI / UDI-DI
- 05060757350952
- Basic UDI-DI
- 506075735T14000SZ
- EMDN Code
- W05019099 Samples collection devices - other
- Device Class
- Class I
- Medical Purpose
- This self-test kit is designed for adults (aged 18 and over) to collect a urine sample and throat and rectal swab samples at home. These samples are then returned to a laboratory and analysed against a variety of biomarkers.
Manufacturer details
- EUDAMED SRN
- GB-PR-000033063
Other devices from Concepta Diagnostics
Properties
Other properties (1)
- Sterile: No