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Helix

by Deka M.E.L.A. SRL

Ref M133D1

Helix (M133D1) is a medical device (EU MDR Class IIb; EMDN category multi–platform laser) made by Deka M.E.L.A. SRL, registered in EUDAMED on 17 Jan 2025 (Basic UDI-DI 803410851M133XXR5), 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 Number803410851M133XXR5 Basic UDI-DI 08034108513324UDI-DIDate17 Jan 2025RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Hemera/Helix
Model / reference
M133D1
Primary DI / UDI-DI
08034108513324
Basic UDI-DI
803410851M133XXR5
EMDN code
Z12011019 Multi–platform laser
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 MULTI–PLATFORM 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)