Assoluto
Ref Assoluto
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 | Number805527109ASSOLUTO8W | Date31 Jul 2026 | StatusActive |
Certificates
No notified-body 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- Withdrawn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
- Assoluto
- Model / Reference
- Assoluto
- Primary DI / UDI-DI
- 08053808349347
- Basic UDI-DI
- 805527109ASSOLUTO8W
- Direct Marketing DI
- 08053808349347
- EMDN Code
- V080702 Non active anti-decubitus medical mattresses
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000056543
Other devices from Bisniflex S.r.l.
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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