Identity
- Trade Name
- ONDA PLUS EUDAMED
- Device Name
- ONDA EUDAMED
- Model / Reference
- M116M1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034108511047 EUDAMED
- Basic UDI-DI
- B-08034108511047 EUDAMED
- EMDN Code
- Z120608 MICROWAVE THERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Microwave ablation system probe, non-powered
Onda Plus by Deka M.e.l.a. Srl — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08034108511047 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
- EUDAMED SRN
- IT-MF-000007389
Sources (1)
- EUDAMED cd165335-d74c-4173-a90e-57a73db3a307 61 fields · synced Jul 12, 2026