Orthopedic Pillow Enso
by Onsen Sp. z o.o. EUDAMED
Active
Ref 5905868656848Model Purotex
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5905868656A02174 | Date11 Feb 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Poduszka ortopedyczna Enso
- Model / Reference
- Purotex, 5905868656848
- Primary DI / UDI-DI
- 59058686568488
- Basic UDI-DI
- 5905868656A02174
- EMDN Code
- V080302 Patient positioning medical cushions
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000037523
Other devices from Onsen Sp. z o.o.
Properties
Other properties (13)
- Sterile: No
- 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