Arcus, Padding, L/XL
by Promedics Orthopaedics Limited EUDAMED
Withdrawn
Ref 80437-51-60
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number50554741B77V | Date6 Aug 2026 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Withdrawn
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Ankle/Footwear
- Model / Reference
- 80437-51-60
- Primary DI / UDI-DI
- 05056420611949
- Basic UDI-DI
- 50554741B77V
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- GB-MF-000008558
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Promedics Orthopaedics Limited
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