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Smartlipo

by Deka M.E.L.A. SRL

Ref M053H2, M053H3

Smartlipo (M053H2) is a Class IIb device made by Deka M.E.L.A. SRL, registered in EUDAMED on 18 Feb 2026 (Basic UDI-DI B-08034108510323), active as of 22 Oct 2026.

Active European Union

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/MDD NumberB-08034108510323 Basic UDI-DI Date18 Feb 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Trade name
Smartlipo
SMARTLIPO_10
Model / reference
M053H2, M053H3
Primary DI / UDI-DI
08034108510323, 08034108510170
Basic UDI-DI
B-08034108510323, B-08034108510170
EMDN code
Z12011017 Neodymium surgical laser
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000007389

Similar devices in this category

Other devices filed under NEODYMIUM SURGICAL LASER.

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Properties

  • Sterilise before use
Other properties (11, all answered No)