Onda Plus
Ref M116M1
Onda Plus (M116M1) 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-08034108511047), active as of 22 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-08034108511047 08034108511047 | Date17 Feb 2026 | StatusActive |
Official records
- EUDAMED public site B-08034108511047
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Onda
- Model / reference
- M116M1
- Primary DI / UDI-DI
- 08034108511047
- Basic UDI-DI
- B-08034108511047
- 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
From the manufacturer
Manufacturer's product page: Onda Plus
Similar devices in this category
Other devices filed under MICROWAVE THERAPY EQUIPMENT.
- Microwave Ablation Generator KY-2100A by Canyon Medical Inc.
- Swift® SWF-AT01 by Emblation, Ltd.
- Dophi SJ-B02 by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Swift® Interconnect Cable SWF-CA01 by Emblation Limited
- Microwave Ablation Generator KY-2000A by Canyon Medical Inc.
- Swift® SWF-GE01 by Emblation, Ltd.
- Swift System SWF-SYS by Emblation Limited