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Syst'am PEOL0002120

by System Assistance Medical

Ref PEOL0002120

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number37003686PEOL000212013G Basic UDI-DI 03700368623442UDI-DIDate16 Apr 2026RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
SYST'AM by Stryker Eole 120
Model / Reference
PEOL0002120
Primary DI / UDI-DI
03700368623442
Basic UDI-DI
37003686PEOL000212013G
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