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Pure Air 8 Acute Dynamic Mattress System

by Winncare PAC Ltd EUDAMED

Active European Union

Ref PUR-8-AC

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05056461915099 Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
PUR-8-AC
Primary DI / UDI-DI
05056461915099
Basic UDI-DI
B-05056461915099
EMDN Code
V080701 Active anti-decubitus medical mattresses
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000028325
Authorised representative
WINNCARE FRANCE FR-AR-000007194

Other devices from Winncare PAC Ltd

See all devices from Winncare PAC Ltd →

Properties

Show properties
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No