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Dornier MedTech

by Dornier MedTech America, Inc. 24 variants

Part of a family of 34 devices: see the family page

Ref K2016578

Dornier MedTech (K2016578) is a device classified as Class IIa in the EU and Class II in the US made by Dornier MedTech America, Inc., registered in EUDAMED on 7 May 2026 (Basic UDI-DI 081011602LFC6B), cleared under FDA 510(k) K123385 on 14 Dec 2012 and listed in FDA GUDID since 28 Jun 2023 (UDI-DI 00810116023158), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123385

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081011602LFC6B Basic UDI-DI 00810116023158UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810116023158 UDI-DI Date28 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK123385 Date14 Dec 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081011602LFC6B registered 7 May 2026 Active
  • FDA 510(k) K123385 decided 14 Dec 2012 Active
  • FDA GUDID UDI-DI 00810116023158 listed 28 Jun 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K123385
  2. Listed FDA GUDID 00810116023158
  3. Registered EUDAMED 081011602LFC6B

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Dornier Reusable 270um HeatFlex High Energy Fiber EUDAMED
Dornier MedTech GUDID
Generic name
Laser lithotripsy system
Device name
Dornier Laser Fiber Cables
Model / Ref / Catalog
K2016578, DMTL SmartFlex 270 High Energy Reusable (5X)
Primary DI / UDI-DI
00810116023158
Basic UDI-DI
081011602LFC6B
Direct marketing DI
00810116023158
510(k) Number
FDA product code
GEX
EMDN code
Z12011085 Laser surgery instruments - consumables
GMDN term
Laser lithotripsy system
Device class
Class IIa 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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
K2016578
GUDID
DMTL SmartFlex 270 High Energy Reusable (5X)
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Laser lithotripsy system

Cleared under the same submission (K123385)

and 8 more cleared under K123385

Similar devices in this category

Other devices filed under LASER SURGERY INSTRUMENTS - CONSUMABLES.

Other devices from Dornier MedTech America, Inc.

See all devices from Dornier MedTech America, Inc. →

Properties

  • Supplied sterile
  • Reusable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)