Carbon Fiber Rods 250 L. Small
Ref 201000-R00-S
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 | Number62055328200000GY 00620553281512 | Date17 Jan 2025 | 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- Withdrawn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
- Xtern Foot Drop Orthotics - Plastic Parts Replacement
- Model / Reference
- 201000-R00-S
- Primary DI / UDI-DI
- 00620553281512
- Basic UDI-DI
- 62055328200000GY
- EMDN Code
- Y061280 Lower limb orthoses - accessories
- Device Class
- Class I
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CA-MF-000032108
- Authorised representative
- OKO SOLUTION FR-AR-000006781
Other devices from Turbomed Orthotics inc.
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