Hardrock Size 5
Ref 8205Model Hardrock
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 | Number50564089SMUK010T4 05056408925853 | Date21 May 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- Withdrawn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
- Hardrock Size 1
- Model / Reference
- Hardrock, 8205
- Primary DI / UDI-DI
- 05056408925853
- Basic UDI-DI
- 50564089SMUK010T4
- EMDN Code
- Y180939 Modular posture systems
- Device Class
- Class I
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- GB-MF-000010683
- Authorised representative
- Evolution Healthcare Ltd XI-AR-000047925
Other devices from Smirthwaite 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