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Valleylab VLFT10FXGEN

by Covidien LP

Ref VLFT10FXGEN

Valleylab VLFT10FXGEN is a device classified as Class IIb in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 8 Sep 2026 (Basic UDI-DI 0763000B00014427R), cleared under FDA 510(k) K241085 on 12 Jul 2024 and listed in FDA GUDID since 3 Oct 2024 (UDI-DI 10884521829527), active as of 24 Oct 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241085

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00014427R Basic UDI-DI 10884521829527UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521829527 UDI-DI Date3 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241085 Date12 Jul 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00014427R registered 8 Sep 2026 Active
  • FDA 510(k) K241085 decided 12 Jul 2024 Active
  • FDA GUDID UDI-DI 10884521829527 listed 3 Oct 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K241085
  2. Listed FDA GUDID 10884521829527
  3. Registered EUDAMED 0763000B00014427R

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  • Withdrawn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
ValleylabTM EUDAMED
Valleylab GUDID
Generic name
Electrosurgical system generator
Device name
VLFT10FXGEN
Model / reference
VLFT10FXGEN
Primary DI / UDI-DI
10884521829527
Basic UDI-DI
0763000B00014427R
Direct marketing DI
10884521829527
510(k) Number
FDA product code
GEI, OCL
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Electrosurgical system generator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Netherlands
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: Electrosurgical system generator

Cleared under the same submission (K241085)

Similar devices in this category

Other devices filed under ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE.

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Properties

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