Skip to content

Echolaser X4

by El.en. SpA

Ref M095F1, M095E1

Echolaser X4 (M095F1) is a medical device (EU MDR Class IIb; EMDN category diode surgical laser) made by El.en. SpA, registered in EUDAMED on 21 Dec 2021 (Basic UDI-DI 805701776M095XX3L), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805701776M095XX3L Basic UDI-DI Date21 Dec 2021RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
M095F1, M095E1
Primary DI / UDI-DI
08057017760412, 08057017760375
Basic UDI-DI
805701776M095XX3L
EMDN code
Z12011016 Diode surgical laser
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000007370

Similar devices in this category

Other devices filed under DIODE SURGICAL LASER.

Other devices from El.en. SpA

Properties

Other properties (14, all answered No)