Onda
Ref M116A1
Onda (M116A1) is a medical device (EU MDD Class IIb; EMDN category microwave therapy equipment) made by Deka M.E.L.A. SRL, registered in EUDAMED on 17 Feb 2026 (Basic UDI-DI B-08034108510828), active as of 23 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08034108510828 08034108510828 | Date17 Feb 2026 | StatusActive |
Official records
- EUDAMED public site B-08034108510828
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / reference
- M116A1
- Primary DI / UDI-DI
- 08034108510828
- Basic UDI-DI
- B-08034108510828
- EMDN code
- Z120608 Microwave therapy equipment
- Device class
- Class IIb
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000007389
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