ONA3
by ORTHO24 Spółka Z Ograniczoną Odpowiedzialnością Poland EUDAMED
Ref Lewa_XS
EMDN Y060609
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number59049170981001WE | Date6 Nov 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Orteza nadgarstka
- Model / Reference
- Lewa_XS
- Primary DI / UDI-DI
- 05904917098257
- Basic UDI-DI
- 59049170981001WE
- Direct Marketing DI
- 05904917098257
- EMDN Code
- Y060609 Wrist (forearm) orthoses
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000034742
Other devices from ORTHO24 Spółka Z Ograniczoną Odpowiedzialnością
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED c5f50697-69ae-4f50-94f8-5e82861bfaab