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PressureGuard Powered Mattresses

by Span-America Medical Systems, Inc. EUDAMED

Active European Union

Ref 93567Model PressureGuard

Overview

PressureGuard Powered Mattresses are a premium line of pressure-sensitive mattresses designed to provide optimal support and comfort for individuals with spinal cord injuries. These innovative devices utilize advanced materials and technology to deliver unparalleled relief from pressure sores, pain, and discomfort, allowing users to live life to the fullest.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++H933PRESSUREGUARDPWRY7 Basic UDI-DIDate13 May 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
PressureGuard, 93567
Primary DI / UDI-DI
H93393567
Basic UDI-DI
++H933PRESSUREGUARDPWRY7
EMDN Code
V080701 Active anti-decubitus medical mattresses
Device Class
Class I
Market of Registration
Norway

Manufacturer details

EUDAMED SRN
US-MF-000002745
Authorised representative
Advena SRL IT-AR-000051131

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Properties

Other properties (13)

  • Sterile: 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