Orteza palcowa ręki RS1 (Ortopedio by Synoptis)
by Private Enterprise "Remed" EUDAMED
Active
Ref 04820183234575Model R8310
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number018323R8310TL | Date24 Jun 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- Withdrawn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
- Device Name
- Hand finger orthosis
- Model / Reference
- R8310, 04820183234575
- Primary DI / UDI-DI
- 04820183234575
- Basic UDI-DI
- 018323R8310TL
- EMDN Code
- Y060606 Hand orthoses
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- UA-MF-000056451
- Authorised representative
- GSI-CERT German Scientific Institute for Quality, Testing and Certification GmbH DE-AR-000056188
Other devices from Private Enterprise "Remed"
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