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Onda Pro

EUDAMED

Class IIb (EU MDR)

Ref M116N2Ref M116N1

by Deka M.e.l.a. Srl

Identity

Trade Name
ONDA PRO EUDAMED
Device Name
ONDA PRO EUDAMED
ONDA EUDAMED
Model / Reference
M116N2 EUDAMED
M116N1 EUDAMED

Identifiers

Primary DI / UDI-DI
08034108513232 EUDAMED
08034108512396 EUDAMED
Basic UDI-DI
803410851M116XXR6 EUDAMED
B-08034108512396 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

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: Microwave ablation system probe, non-powered

Onda Pro by Deka M.e.l.a. Srl — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Microwave ablation system probe, non-powered.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Deka M.e.l.a. Srl
EUDAMED SRN
IT-MF-000007389

Sources (2)

  • EUDAMED 07cd3349-8e7f-4946-a495-7286e9f368ad 61 fields · synced Sep 17, 2026
  • EUDAMED 2dc56a0f-d756-4872-a46d-f72b69817701 61 fields · synced May 17, 2026