Comfortia Shoulder
by Wellcast Spółka z o.o. EUDAMED
Active
Ref CMC0101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number590187862CMS0101HV | Date13 Aug 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- Withdrawn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
- Comfortia Shoulder
- Model / Reference
- CMC0101
- Primary DI / UDI-DI
- 05901878628493, 05901878628486, 05901878628462, 05901878628431, 05901878628448, 05901878628455
- Basic UDI-DI
- 590187862CMS0101HV
- EMDN Code
- Y060621 Shoulder orthoses
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000009268
Other devices from Wellcast Spółka z o.o.
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