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Synchro QS4

by Deka M.E.L.A. SRL

Ref M109A1

Synchro QS4 (M109A1) is a medical device (EU MDD Class IIb; EMDN category laser surgery instruments - hardware accessories) made by Deka M.E.L.A. SRL, registered in EUDAMED on 18 Feb 2026 (Basic UDI-DI B-08034108510347), 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-08034108510347 Basic UDI-DI 08034108510347UDI-DIDate18 Feb 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
M109A1
Primary DI / UDI-DI
08034108510347
Basic UDI-DI
B-08034108510347
EMDN code
Z12011080 Laser surgery instruments - hardware accessories
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 LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

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 (11, all answered No)