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OCT9/5040

by Vicair B.V. EUDAMEDGUDID

Active European Union

Ref OCT9/5040Model Vicair cushions

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08717261056272 UDI-DIDate14 Dec 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8717261VIC001VK Basic UDI-DIDate10 Jul 2023RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
O2 ACTIVE 9 20x16x3.5"
Generic Name
Wheelchair seat cushion
Model / Reference
Vicair cushions, OCT9/5040
Primary DI / UDI-DI
08717261056272
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
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Depth — 16 Inch
Width — 20 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