Class I Instruments
by Ortho Solutions UK Ltd EUDAMED
Active
Ref OS328101-NSModel Non-Invasive Devices and Accessories
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number50556629257M | Date12 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Class I Instruments
- Model / Reference
- Non-Invasive Devices and Accessories, OS328101-NS
- Primary DI / UDI-DI
- 05055662957037
- Basic UDI-DI
- 50556629257M
- Direct Marketing DI
- 05055662957037
- EMDN Code
- S010401 Trays, baskets, tubs for sterilisation and their components
- Device Class
- Class I
Manufacturer details
- EUDAMED SRN
- GB-MF-000030101
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Ortho Solutions UK, Ltd.
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