Isabelle
by Florett GmbH EUDAMED
Active
Ref 06325
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4040261stretchF4 | Date13 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- Stretchschuhe
- Model / Reference
- 06325
- Primary DI / UDI-DI
- 04040261341630, 04040261056060, 04040261056053, 04040261056008, 04040261055995, 04040261486430, 04040261341593, 04040261486447, 04040261341715, 04040261341616, 04040261341623, 04040261056046, 04040261056114, 04040261341654, 04040261056077, 04040261486461, 04040261341739, 04040261341722, 04040261056022, 04040261341678, 04040261056039, 04040261056121, 04040261486454, 04040261341708, 04040261056145, 04040261056138, 04040261341685, 04040261056091, 04040261341692, 04040261056084, 04040261056015, 04040261056107, 04040261341586, 04040261341647, 04040261341661
- Basic UDI-DI
- 4040261stretchF4
- EMDN Code
- Y063303 Ready-made orthotic shoes
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000012054
Other devices from Florett GmbH
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No