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Smartxide Hs

by Deka M.E.L.A. SRL 2 variants

Part of a family of 8 devices: see the family page

Ref M079Q2

Smartxide Hs (M079Q2) is a medical device (EU MDR Class IIb; EMDN category carbon dioxide surgical laser) made by Deka M.E.L.A. SRL, registered in EUDAMED on 23 Feb 2026 (Basic UDI-DI B-08034108510040), active as of 22 Oct 2026.

Active European Union

CE MDR CE MDD

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 NumberB-08034108510040 Basic UDI-DI 08034108510040UDI-DIDate23 Feb 2026RegisteredStatusActive
European UnionCE/MDD NumberB-08034108510040 Basic UDI-DI 08034108510040UDI-DIDate23 Feb 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device name
SMARTXIDE family
Model / reference
M079Q2
Primary DI / UDI-DI
08034108510040
Basic UDI-DI
B-08034108510040, 803410851M079XXSL
EMDN code
Z12011005 Carbon dioxide surgical laser
Device class
Class IIb
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000007389

Similar devices in this category

Other devices filed under CARBON DIOXIDE SURGICAL LASER.

Other devices from Deka M.E.L.A. SRL

See all devices from Deka M.E.L.A. SRL →

Properties

  • Sterilise before use
Other properties (13, all answered No)