ONE-I Plateau à élévation motorisée
by Nidek SA EUDAMED
Active
Ref HUC1500
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number37008623UCO007BT | Date6 Nov 2024 | 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- Withdrawn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
- Consultation Unit One-I
- Model / Reference
- HUC1500
- Primary DI / UDI-DI
- 03700862300047
- Basic UDI-DI
- 37008623UCO007BT
- EMDN Code
- Q0299 Ophthalmic devices - other
- Device Class
- Class I
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000000493
Other devices from Nidek SA
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