Docking Case
by SurgEase Innovations Ltd. 2 variants
Ref LX1-DCK-303Model LumenEye X1
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506076828LUX1EY 05060768280392 | Date24 Sep 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- LumenEye X1
- Model / Reference
- LumenEye X1, LX1-DCK-303
- Primary DI / UDI-DI
- 05060768280392
- Basic UDI-DI
- 506076828LUX1EY
- Direct Marketing DI
- 05060768280392
- EMDN Code
- Z1203020202 Transportable/portable multi–parameter patient monitors
- Device Class
- Class I
- EU market of registration
- Portugal
Manufacturer details
- EUDAMED SRN
- GB-MF-000016541
- Authorised representative
- Advena SRL IT-AR-000051131
Other devices from Surgease Innovations Limited
Properties
Other properties (12)
- Sterile: No
- Implantable: 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