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Ventoux

by Flight Medical Innovations Ltd. 20 variants

Ref VX-12-1-0N1Model VC3

Ventoux (VX-12-1-0N1) is a device classified as Class IIb in the EU and Class II in the US made by Flight Medical Innovations Ltd., registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI B-07290017856452), cleared under FDA 510(k) K223120 on 2 Dec 2024 and listed in FDA GUDID since 21 Apr 2026 (UDI-DI 07290017856452), active as of 22 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223120

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290017856452 Basic UDI-DI 07290017856452UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290017856452 UDI-DI Date21 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223120 Date2 Dec 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290017856452 registered 29 Sep 2026 Active
  • FDA 510(k) K223120 decided 2 Dec 2024 Active
  • FDA GUDID UDI-DI 07290017856452 listed 21 Apr 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K223120
  2. Listed FDA GUDID 07290017856452
  3. Registered EUDAMED B-07290017856452

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
General-purpose intensive-care ventilator
Model / Ref / Catalog
VC3, VX-12-1-0N1, VC3 VX-12-1-0N1
Primary DI / UDI-DI
07290017856452
Basic UDI-DI
B-07290017856452
510(k) Number
FDA product code
CBK
EMDN code
Z1203010599 Pulmonary ventilators for hospital use - other
GMDN term
General-purpose intensive-care ventilator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5895
EU registration type
Legacy device (under a directive)
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
VC3
VX-12-1-0N1
GUDID
VC3 VX-12-1-0N1
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
IL-MF-000025118
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under PULMONARY VENTILATORS FOR HOSPITAL USE.

Other devices from Flight Medical Innovations Ltd.

See all devices from Flight Medical Innovations Ltd. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)