Skip to content

Dot Pro

by Deka M.E.L.A. SRL

Part of a family of 41 devices: see the family page

Ref F54001

Dot Pro (F54001) is a medical device (EU MDR Class IIb; EMDN category laser surgery instruments) made by Deka M.E.L.A. SRL, registered in EUDAMED on 16 Dec 2021 (Basic UDI-DI 803410851F49801KD), 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 Number803410851F49801KD Basic UDI-DI 08034108512839UDI-DIDate16 Dec 2021RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Scanning units for CO2 lasers
Model / reference
F54001
Primary DI / UDI-DI
08034108512839
Basic UDI-DI
803410851F49801KD
EMDN code
Z12011099 Laser surgery instruments - other
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000007389

Similar devices in this category

Other devices filed under LASER SURGERY INSTRUMENTS - OTHER.

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)