Identity
- Trade Name
- Vaya Nivello 20mm 38-40 EUDAMED
- Device Name
- Korekcja nierówności EUDAMED
- Model / Reference
- VAYA-ORT-405-3840-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904473792798 EUDAMED
- Basic UDI-DI
- 5903111NIVELLOWW 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
Yes
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
Vaya Nivello 20mm 38-40 by VAYA 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 | 5903111NIVELLOWW | Class I | Active |
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Manufacturer
- Manufacturer
- VAYA Spółka z ograniczoną odpowiedzialnością
- EUDAMED SRN
- PL-MF-000034726
Sources (1)
- EUDAMED 3c0e9e93-fd0c-4822-8f51-e550371c062e 61 fields · synced Oct 6, 2026