Powerstep
by Cuxson Gerrard & Co. Ltd EUDAMED
Active
Ref POW222Model Orthotics
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5012654ORT100M2 | Date7 May 2025 | 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- Withdrawn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
- Orthotics
- Model / Reference
- Orthotics, POW222
- Primary DI / UDI-DI
- 50126542084614
- Basic UDI-DI
- 5012654ORT100M2
- EMDN Code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- GB-MF-000004499
- Authorised representative
- Cuxson Gerrard Healthcare Ltd IE-AR-000003838
Other devices from Cuxson Gerrard & Co. 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