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SmartXide PRO

by Deka M.E.L.A. SRL

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

Ref M079BH1

SmartXide PRO (M079BH1) 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 20 Apr 2023 (Basic UDI-DI 803410851M079XXSL), 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 Number803410851M079XXSL Basic UDI-DI 08034108512693UDI-DIDate20 Apr 2023RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
SMARTXIDE family
Model / reference
M079BH1
Primary DI / UDI-DI
08034108512693
Basic UDI-DI
803410851M079XXSL
EMDN code
Z12011005 Carbon dioxide surgical laser
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000007389

From the manufacturer

Manufacturer's product page: SmartXide Punto

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)