Collection Kit 6
Ref P-Box-A-Var6-5x1165
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 | Number42624479004NS 04262447940523 | Date31 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- Withdrawn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
- Epithelzellen / Vaginal - Probenahme, Aufbewahrungs und Einsende Kit
- Model / Reference
- P-Box-A-Var6-5x1165
- Primary DI / UDI-DI
- 04262447940523
- Basic UDI-DI
- 42624479004NS
- EMDN Code
- W05019099 Samples collection devices - other
- Device Class
- Class I
- Medical Purpose
- Diese Behandlungseinheit dient der Entnahme einer vaginalen Probe durch Abstrich durch Laienanwender:innen in der häuslichen Umgebung, der primären Aufbewahrung, Erhaltung sowie dem Probenversand in ein Kooperationslabor.
Manufacturer details
- EUDAMED SRN
- DE-PR-000043145
Other devices from Remi Health GmbH
Properties
Other properties (1)
- Sterile: No