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El.en. SpA

Active in EUDAMED

Italyfrom SRN EUDAMED SRN IT-MF-000007370

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.

Devices
3
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • EUDAMED 3
Device classes
  • EU Class IIb 2
  • EU Class IIa 1
Top EMDN categories
Identifiers
  • EUDAMED SRN IT-MF-000007370

At a glance

Counted by deviCERTS from registry records

EU certificates

0 of 1 in force. 1 certificate has expired.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate

What El.en. SpA makes

The manufacturer produces multi-modality skin treatment systems for procedures like lipolysis, skin resurfacing, and non-ablative phototherapy, alongside surgical laser systems for dermatology and general surgery. Their portfolio includes diode and carbon dioxide laser devices, microwave hyperthermia applicators, and infrared phototherapy units for musculoskeletal applications. Examples include systems like DEKA Smartlipo for body contouring, DEKA SmartXide² for dermatological treatments, and DEKA Motus AX for musculoskeletal therapy.

These devices are classified under EU Medical Device Regulations as Class II and Class IIa/IIb, with listings in the EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The company is based in Italy.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

  • Echolaser X4 Ref M095F1

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Stimul 1340 Ref M069A2

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EcholaserX4 Ref M095C1

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
IT-MF-000007370
EU VAT number
03137680488
EUDAMED status
Active
EUDAMED registered name
EL.EN. SPA
Registered address
17, Via Baldanzese, 50041, Calenzano (Fi), Italy
Phone
+39 055 8826807
PRRC contact
Andrea Checchi(public in EUDAMED)

EUDAMED certificates1

1 certificate0 valid, 1 expiredMDR 1

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G10 098417 0006 Expired

    Quality management system EU MDR

    Issued
    23 Aug 2021
    Expires
    22 Aug 2026

Frequently asked questions

How many devices does EL.EN. SPA have in the registry?

The registry currently lists 3 devices for EL.EN. SPA. Devices recorded under merged duplicate company entries are counted once.

Which registries list EL.EN. SPA's devices?

Among its 3 most recently registered devices, EL.EN. SPA has devices listed in EUDAMED (3 devices).

What risk classes do EL.EN. SPA's devices fall under?

Among its 3 most recently registered devices, the classes recorded for EL.EN. SPA's devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for EL.EN. SPA?

EUDAMED lists 1 certificate for EL.EN. SPA (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 23 Aug 2021.

What are the newest devices from EL.EN. SPA in the registry?

The most recently registered devices listed for EL.EN. SPA include Echolaser X4, STIMUL 1340 and EcholaserX4.

Generated automatically from registry data and not verified by a human reviewer.