Rolyan Thumb Support Basic Elastic Spica
by Performance Health International LTD EUDAMED
Active
Ref 091239375Model ORTHOPEDICS
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number50283180000000000000013YQ | Date11 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Upper Extremity
- Model / Reference
- ORTHOPEDICS, 091239375
- Primary DI / UDI-DI
- 05028318989966
- Basic UDI-DI
- 50283180000000000000013YQ
- EMDN Code
- Y061803 Partial hand prostheses (including fingers prostheses)
- Device Class
- Class I
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- GB-MF-000003319
- Authorised representative
- AR Experts B.V. NL-AR-000023989
Other devices from Performance Health International LTD
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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