Skip to content

Twain Evo OAM001815

by Quanta System SpA

Ref OAM001815Model Twain IPL

Twain Evo OAM001815 is a device classified as Class IIb in the EU and Class II in the US made by Quanta System SpA, registered in EUDAMED on 16 Jul 2026 (Basic UDI-DI B-08033945935009) and listed in FDA GUDID since 29 Aug 2016 (UDI-DI 08033945935009), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033945935009 Basic UDI-DI 08033945935009UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033945935009 UDI-DI Date29 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08033945935009 registered 16 Jul 2026 Active
  • FDA GUDID UDI-DI 08033945935009 listed 29 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033945935009
  2. Registered EUDAMED B-08033945935009

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Twain IPL EUDAMED
Twain Evo GUDID
Generic name
Light-energy skin surface treatment system applicator
Model / reference
OAM001815, Twain IPL
Primary DI / UDI-DI
08033945935009
Basic UDI-DI
B-08033945935009
FDA product code
GEX
EMDN code
Z12011019 Multi–platform laser
GMDN term
Light-energy skin surface treatment system applicator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Light-energy skin surface treatment system applicator

Similar devices in this category

Other devices filed under MULTI–PLATFORM LASER.

Other devices from Quanta System SpA

See all devices from Quanta System SpA →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)