S1 Integral
by Orthos XXI, Unipessoal Lda 5 variants
Ref 52CN50AFPMAM, 52CNX7AFPMAM, 52CN22AFPMAM, 52CNX6AFPMAM, 52CNX4AFPMAM
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 | Number56004569CANADIANAXW | Date26 Mar 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- Withdrawn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
- Auxiliares de Marcha - Canadiana
- Model / Reference
- 52CN50AFPMAM, 52CNX7AFPMAM, 52CN22AFPMAM, 52CNX6AFPMAM, 52CNX4AFPMAM
- Primary DI / UDI-DI
- 05600456932082, 05600456931313, 05600456931320, 05600456931306, 05600456931283
- Basic UDI-DI
- 56004569CANADIANAXW
- Direct Marketing DI
- 0560045693208205600456931313056004569313200560045693130605600456931283
- EMDN Code
- Y12030601 Elbow crutches
- Device Class
- Class I
- EU market of registration
- Portugal
Manufacturer details
- EUDAMED SRN
- PT-MF-000002787
Other devices from Orthos XXI, Unipessoal Lda
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