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Non-Powered Mattress

by Span-America Medical Systems, Inc. 75 variants

Ref 12527Model Pressure Guard Non-Powered Mattress

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++H933PRESSUREGUARDNP94 Basic UDI-DI H93312527UDI-DIDate20 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberH93312527 UDI-DI Date14 Dec 2023ListedStatusListed 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Span-America
Generic Name
Alternating-pressure bed mattress system
Device Name
Non-Powered Mattress
Model / Ref / Catalog
Pressure Guard Non-Powered Mattress, 12527, CUSTOM CARE NP
Primary DI / UDI-DI
H93312527
Basic UDI-DI
++H933PRESSUREGUARDNP94
FDA Product Code
FNM
EMDN Code
V080702 Non active anti-decubitus medical mattresses
GMDN Term
Alternating-pressure bed mattress 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
Pressure Guard Non-Powered Mattress
12527
GUDID
CUSTOM CARE NP
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
  • Manufacturing Date

Other properties (21)

  • 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