SalineSlush
by S.A.L.F. S.p.A. Laboratorio Farmacologico Italy EUDAMED
Ref HTKE1312BOO EMDN C0399
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805274210SalSluXG | Date21 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- EPT 0477.MDR.26/6293 Issued
Quality management system EU MDR
- Notified body
- Notified body 0477
- Issued
- 18 Sep 2026
- Expires
- 3 Aug 2027
Specification
- Model / Reference
- HTKE1312BOO
- Primary DI / UDI-DI
- 08052742104388
- Basic UDI-DI
- 805274210SalSluXG
- EMDN Code
- C0399 Cardiosurgery and organ transplantation devices - other
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000010720
Other devices from S.A.L.F. S.p.A. Laboratorio Farmacologico
See all devices from S.A.L.F. S.p.A. Laboratorio Farmacologico →
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED d83ccd0b-d579-458c-856e-4efbb972c019