Urias
by Arden Medical Limited 53 variants
Ref 70-003-0
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5065006483U702C 05065006483122 | Date27 Aug 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Urias Non-Sterile Air Splints
- Model / Reference
- 70-003-0
- Primary DI / UDI-DI
- 05065006483122
- Basic UDI-DI
- 5065006483U702C
- EMDN Code
- Y060609 Wrist (forearm) orthoses
- Device Class
- Class I
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- UK-MF-000053945
- Authorised representative
- EUCEREP B.V. NL-AR-000001966
Other devices from Arden Medical Ltd.
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