ORTEX 07J Ortéza zápěstí a prstů ruky
by ORTEX, spol. s r.o. EUDAMED
Active
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number85955714ORTEX07JQ7 | Date20 Jul 2026 | 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- Withdrawn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
- Primary DI / UDI-DI
- 08595571404538
- Basic UDI-DI
- 85955714ORTEX07JQ7
- Direct Marketing DI
- 08595571404538
- EMDN Code
- Y060612 Wrist-hand orthoses
- Device Class
- Class I
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000048500
Other devices from ORTEX, spol. s r.o.
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