RheelaxX
by Yaer SARL EUDAMED
Active
Ref 3770029747015
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3770029747RHEA4 | Date19 Mar 2025 | 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- Withdrawn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
- RheelaxX orthopedic insoles
- Model / Reference
- 3770029747015
- Primary DI / UDI-DI
- 03770029747015
- Basic UDI-DI
- 3770029747RHEA4
- EMDN Code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device Class
- Class I
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000045665
Other devices from Yaer SARL
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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