Identity
- Trade Name
- onda EUDAMED
- Device Name
- onda EUDAMED
- Model / Reference
- onda EUDAMEDOND001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033638323342 EUDAMED
- Basic UDI-DI
- 803363832SWE001BC EUDAMED
- Direct Marketing DI
- 08033638323342 EUDAMED
- EMDN Code
- Z12139001 SHOCK WAVE THERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
onda by Led Spa — Class IIa — 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 | 803363832SWE001BC | Class IIa | Active |
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Manufacturer
- Manufacturer
- LED SpA
- EUDAMED SRN
- IT-MF-000012232
Sources (1)
- EUDAMED 292bafb5-3871-4087-804e-8d790a5e63e5 61 fields · synced Jun 18, 2026