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OVR10/4545

by Vicair B.V.

Ref OVR10/4545Model Vicair cushions

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08717261044057 UDI-DI Date14 Dec 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8717261VIC001VK Basic UDI-DI 08717261044057UDI-DIDate10 Jul 2023RegisteredStatusActive

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.

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  • Withdrawn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
O2 VECTOR 10 18x18x4"
Generic Name
Wheelchair seat cushion
Model / Reference
Vicair cushions, OVR10/4545
Primary DI / UDI-DI
08717261044057
Basic UDI-DI
8717261VIC001VK
FDA Product Code
IMP
EMDN Code
V08030102 Non-active anti-decubitus medical cushions
GMDN Term
Wheelchair seat cushion
Device Class
Class I
Regulation Number
890.3920
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Width — 18 Inch
Depth — 18 Inch

Manufacturer details

EUDAMED SRN
NL-MF-000002604

Other devices from Vicair B.V.

See all devices from Vicair B.V. →

Properties

  • Premarket Exempt
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No