Rigidní ortéza 010D, 0°, vel.5 / 65 cm - lýtko
Ref 010D
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 | Number859404276049K3 | Date24 Sep 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- Withdrawn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
- Rigidní ortéza 010D,0°,vel.5 / 65 cm - lýtkoRigidní ortéza 010D,0°,vel.3 / 55 cm - lýtkoRigidní ortéza 010D,0°,vel.0 / 30 cm - lýtkoRigidní ortéza 010D,0°,vel.4 / 60 cm - lýtkoRigidní ortéza 010D,0°,vel.2 / 50 cm - lýtko
- Device Name
- Rigidní ortéza 010D
- Model / Reference
- 010D
- Primary DI / UDI-DI
- 08594042764607, 08594042764584, 08594042764553, 08594042764591, 08594042764577
- Basic UDI-DI
- 859404276049K3
- EMDN Code
- Y061209 Knee 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