# El.en. SpA

> Medical device manufacturer record on deviCERTS, compiled from public registries. El.en. SpA is a medical device manufacturer based in Italy, with 3 devices listed in EUDAMED (EU Class IIb and IIa) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/elen-spa>
- Country: Italy (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED
- EUDAMED SRN: IT-MF-000007370

## Figures

- Devices: 3
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: EUDAMED 3
- Device classes: EU Class IIb 2, EU Class IIa 1
- EMDN [Z12 Instruments for functional explorations and therapeutic interventions](https://devicerts.com/categories/emdn/Z12): 3 devices

## Devices

The first 3 of 3, in the order of the canonical page, which lists them all.

- [Echolaser X4](https://devicerts.com/devices/echolaser-x4-m095f1) · ref M095F1 · Class IIb · EUDAMED · status: Active
- [Stimul 1340](https://devicerts.com/devices/stimul-1340-m069a2) · ref M069A2 · Class IIa · EUDAMED · status: Active
- [EcholaserX4](https://devicerts.com/devices/echolaserx4-m095c1) · ref M095C1 · Class IIb · EUDAMED · status: Active

## EU certificates

- G10 098417 0006 · Quality management system · MDR · notified body TÜV SÜD Product Service GmbH · issued 2021-08-23 · expires 2026-08-22 · status: issued

## Source and citation

- Cite as: El.en. SpA. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/elen-spa (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/elen-spa.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/elen-spa
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.