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Non-Powered Mattress

by Span-America Medical Systems, Inc. 4 variants

Ref CF8453-29, 57528, EVCF8038-HS-29, 33865, 61300, 8310CEC, CF8435-NS-500, 64352, 67078, CF8048-13, EVCF8060-HS-29Model Pressure Guard Non-Powered Mattress, PressureGuard

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, self-declared

Class I: no certifier involved

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++H933PRESSUREGUARDNP94 Basic UDI-DI Date20 Mar 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Non-Powered Mattress
PressureGuard Powered Mattresses
Model / Reference
Pressure Guard Non-Powered Mattress, CF8453-29, 57528, EVCF8038-HS-29, 33865, 61300, PressureGuard, 8310CEC, CF8435-NS-500, 64352, 67078, CF8048-13, EVCF8060-HS-29
Primary DI / UDI-DI
H933CF845329, H93357528, H933EVCF8038HS29, H93333865, H93361300, H9338310CEC0, H933CF8435NS500, H93364352, H93367078, H933CF804813, H933EVCF8060HS29
Basic UDI-DI
++H933PRESSUREGUARDNP94, ++H933PRESSUREGUARDPWRY7
EMDN Code
V080702, V080701
Device Class
Class I
Market of Registration
Norway

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

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