0793-A-35
Ref 0793-A-35Model FOOTWEAR
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 | Number84356621FOOTWEARE2 08435662160823 | Date3 Dec 2024 | 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- Withdrawn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
- Footwear
- Model / Reference
- FOOTWEAR, 0793-A-35
- Primary DI / UDI-DI
- 08435662160823
- Basic UDI-DI
- 84356621FOOTWEARE2
- EMDN Code
- Y063303 Ready-made orthotic shoes
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- ES-MF-000006249
Other devices from Calzamedi, S.L.
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