SLE6000 - Croatia (Packaging)
by SLE Ltd United Kingdom EUDAMED
Ref Z6000 EMDN Z1203010503
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-05051380006149 | Date23 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Device Name
- SLE6000 Infant Ventilator
- Model / Reference
- Z6000
- Primary DI / UDI-DI
- 05051380006149
- Basic UDI-DI
- B-05051380006149
- EMDN Code
- Z1203010503 Neonatal/paediatric pulmonary ventilators
- Device Class
- Class IIb
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- GB-MF-000004155
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from SLE Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED c8b3166d-a6c2-4755-89cd-c93d82ed0be2