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Dornier Thulio

by Dornier MedTech GmbH

Ref K2016000

Dornier Thulio (K2016000) is a device classified as Class IIb in the EU and Class II in the US made by Dornier Medtech GmbH, registered in EUDAMED on 7 Oct 2022 (Basic UDI-DI 4049958DornierThulioF8) and listed in FDA GUDID since 27 Jan 2023 (UDI-DI 04049958004551), active as of 22 Oct 2026.

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

CE MDR

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04049958004551 UDI-DI Date27 Jan 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4049958DornierThulioF8 Basic UDI-DI 04049958004551UDI-DIDate7 Oct 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4049958DornierThulioF8 registered 7 Oct 2022 Active
  • FDA GUDID UDI-DI 04049958004551 listed 27 Jan 2023 Listed

Timeline

2 dated events

  1. Registered EUDAMED 4049958DornierThulioF8
  2. Listed FDA GUDID 04049958004551

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
General/multiple surgical solid-state laser system
Model / Ref / Catalog
K2016000
Primary DI / UDI-DI
04049958004551
Basic UDI-DI
4049958DornierThulioF8
FDA product code
GEX
EMDN code
Z12011006 Diode–pumped solid–state (dpss) surgical laser
GMDN term
General/multiple surgical solid-state laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
EU market of registration
Germany
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.

Manufacturer details

EUDAMED SRN
DE-MF-000009774

Similar devices in this category

Other devices filed under DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER.

Other devices from Dornier Medtech GmbH

See all devices from Dornier Medtech GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)