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Syst'am PEOL0002

by System Assistance Medical EUDAMED

Active European Union

Ref SYST'AM PEOL0002

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number37003686PEOL00021TX Basic UDI-DIDate16 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
SYST'AM by Stryker Eole
Model / Reference
SYST'AM PEOL0002
Primary DI / UDI-DI
03700368621615
Basic UDI-DI
37003686PEOL00021TX
EMDN Code
V080701 Active anti-decubitus medical mattresses
Device Class
Class IIa
Medical Purpose
The devices are intended to support the prevention and management of pressure ulcers in patients at risk. They achieve their intended medical effect through physical and mechanical means, including pressure redistribution, improved ventilation, and reduction of localized pressure, thereby promoting skin perfusion and reducing tissue stress.

Manufacturer details

EUDAMED SRN
FR-PR-000003519

Other devices from System Assistance Medical

See all devices from System Assistance Medical →

Properties

Other properties (1)

  • Sterile: No