uSINE
by HiCura Medical Pte Ltd Singapore EUDAMED
Ref ULS-01
EMDN Z11040182
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8881300520ULSEE | Date22 Apr 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- uSINE® (Ultrasound guided spinal landmark identification system)
- Model / Reference
- ULS-01
- Primary DI / UDI-DI
- 88813005200072
- Basic UDI-DI
- 8881300520ULSEE
- EMDN Code
- Z11040182 Ultrasound scanners - software accessories
- Device Class
- Class IIa
- Market of Registration
- Finland
Manufacturer details
- EUDAMED SRN
- SG-MF-000024811
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from HiCura Medical Pte Ltd
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 8d7ec806-a7df-4807-bdad-f029d5565d73