Ortéza hlezenní s křížovým tahem N60B, vel.1, vyšší
Ref N60B
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 | Number859404276004JD | Date29 Jul 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- Withdrawn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
- Trade Name
- Ortéza hlezenní s křížovým tahem N60B, vel.1, vyššíOrtéza hlezenní s křížovým tahem N60B, vel.0, vyššíOrtéza hlezenní s křížovým tahem N60B, vel.3, vyššíOrtéza hlezenní s křížovým tahem N60B, vel.2, vyššíOrtéza hlezenní s křížovým tahem N60B, vel.4, vyšší
- Device Name
- Hlezenní ortéza N60B
- Model / Reference
- N60B
- Primary DI / UDI-DI
- 08594042762085, 08594042763860, 08594042762108, 08594042762092, 08594042762504
- Basic UDI-DI
- 859404276004JD
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000001007
Other devices from HANDICAP, a.s.
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