Identity
- Trade Name
- Orteza stopy EUDAMED
- Device Name
- Orteza stopy EUDAMED
- Model / Reference
- OSS-OS-06 EUDAMEDOSS-OS-06 L/L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05900949768236 EUDAMED
- Basic UDI-DI
- 59009497OSS-OS-06R8 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Orteza stopy by REH4MAT Spółka z ograniczoną odpowiedzialnością — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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-06R8 | Class I | Active |
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Manufacturer
- Manufacturer
- REH4MAT Spółka z ograniczoną odpowiedzialnością
- EUDAMED SRN
- PL-MF-000009271
Sources (1)
- EUDAMED 4685be0a-282d-4e37-8fc6-471cd4e6851b 61 fields · synced Oct 6, 2026