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PressureGuard Powered Mattresses

by Span-America Medical Systems, Inc. 119 variants

Ref 2291329Model PressureGuard

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++H933PRESSUREGUARDPWRY7 Basic UDI-DI H9332291329UDI-DIDate13 May 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID NumberH9332291329 UDI-DI Date11 Feb 2017ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDR Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
PressureGuard®
Generic Name
Alternating-pressure bed mattress overlay system
Device Name
PressureGuard Powered Mattresses
Model / Ref / Catalog
PressureGuard, 2291329, APM II
Primary DI / UDI-DI
H9332291329
Basic UDI-DI
++H933PRESSUREGUARDPWRY7
FDA Product Code
FNM
EMDN Code
V080701 Active anti-decubitus medical mattresses
GMDN Term
Alternating-pressure bed mattress overlay system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.5550
Market of Registration
Norway
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PressureGuard
2291329
GUDID
APM II
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

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

Other devices from Span-America Medical Systems, Inc.

See all devices from Span-America Medical Systems, Inc. →

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