Identity
- Trade Name
- Orteza stopy EUDAMED
- Device Name
- ORTEZA STOPY EUDAMED
- Model / Reference
- OSS-OS-03 EUDAMEDOSS-OS-03 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05900949713700 EUDAMED
- Basic UDI-DI
- 59009497OSS-OS-03R2 EUDAMED
- Direct Marketing DI
- 05900949713700 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Orteza stopy by REH4MAT Spółka z ograniczoną odpowiedzialnością — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 59009497OSS-OS-03R2 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- REH4MAT Spółka z ograniczoną odpowiedzialnością
- EUDAMED SRN
- PL-MF-000009271
Sources (1)
- EUDAMED d2091d21-333c-4182-a7d9-083ac2185a1d 61 fields · synced Oct 6, 2026