Single Site Swab Sample Collection Kit (Vaginal)
by Concepta Diagnostics EUDAMED
Active
Ref T11000
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506075735T11000SC | Date7 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Single Site Swab Sample Collection Kit (Vaginal) (BOD)
- Model / Reference
- T11000
- Primary DI / UDI-DI
- 05060757350921
- Basic UDI-DI
- 506075735T11000SC
- 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) for the collection of a vaginal swab sample to be performed at home. This sample is 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
Show properties
Other properties (1)
- Sterile: No