Skip to content

Ventoux VC2 VX-08-0-0N1

by Flight Medical Innovations Ltd

Ref VX-08-0-0N1Model VC2

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290017856094 Basic UDI-DI 07290017856094UDI-DIDate4 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290017856094 UDI-DI Date21 Apr 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Ventoux
Generic Name
General-purpose intensive-care ventilator
Model / Ref / Catalog
VC2, VX-08-0-0N1, VC2 VX-08-0-0N1
Primary DI / UDI-DI
07290017856094
Basic UDI-DI
B-07290017856094
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 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
VC2
VX-08-0-0N1
GUDID
VC2 VX-08-0-0N1
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K223120)

Show all (12)

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 (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No