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Conformx

by ArjoHuntleigh AB 3 variants

Ref CS000/000Model 120PM000/000

Withdrawn Withdrawn in European Union.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Was authorized under CE MDR, withdrawn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Withdrawn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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5060693520174W9 Basic UDI-DI 05056341676096UDI-DIDate19 Jul 2024RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number05056341676096 UDI-DI Date30 Jul 2022ListedStatusListed GUDID: not 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  • Withdrawn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  • European Union CE/MDR Withdrawn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

Generic Name
Foam-filled bed mattress overlay
Device Name
Pentaflex
Model / Reference
120PM000/000, CS000/000
Primary DI / UDI-DI
05056341676096
Basic UDI-DI
5060693520174W9
FDA Product Code
IKY
EMDN Code
V080702 Non active anti-decubitus medical mattresses
GMDN Term
Foam-filled bed mattress overlay
Device Class
Class I
Regulation Number
880.5150
EU market of registration
Austria
GUDID distribution status
Not in Commercial Distribution

Manufacturer details

EUDAMED SRN
SE-MF-000000696

Other devices from Arjohuntleigh AB

See all devices from Arjohuntleigh AB →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No