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VentX Footswitch

by Solta Medical, Inc. 2 variants

Part of a family of 7 devices: see the family page

Ref 120-0049Model VaserLipo

VentX Footswitch (120-0049) is a device classified as Class I in the EU and Class II in the US made by Solta Medical, Inc., registered in EUDAMED on 13 Jun 2023 (Basic UDI-DI 081699502B0012W9) and listed in FDA GUDID since 1 May 2021 (UDI-DI 00816995027416), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081699502B0012W9 Basic UDI-DI 00816995027416UDI-DIDate13 Jun 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00816995027416 UDI-DI Date1 May 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081699502B0012W9 registered 13 Jun 2023 Active
  • FDA GUDID UDI-DI 00816995027416 listed 1 May 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816995027416
  2. Registered EUDAMED 081699502B0012W9

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  • Withdrawn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

Trade name
VentX Footswitch EUDAMED
Vaser GUDID
Generic name
Foot-switch, electrical
Model / Ref / Catalog
VaserLipo, 120-0049
Primary DI / UDI-DI
00816995027416
Basic UDI-DI
081699502B0012W9
FDA product code
MUU
EMDN code
Z12010880 Instruments for ultrasonic surgery - hardware accessories
GMDN term
Foot-switch, electrical
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.5040
System or procedure pack
System which is a device in itself
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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
US-MF-000018343
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Ultrasonic surgical system generator

Similar devices in this category

Other devices filed under INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES.

Other devices from Solta Medical, Inc.

See all devices from Solta Medical, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)