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ProFoam Wedge Inclination Kit

by Pearl Technology AG

Ref 5018-A

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764017806ProFoamTH Basic UDI-DI 07640178061781UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640178061781 UDI-DI Date17 Dec 2025ListedStatusListed 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  • Withdrawn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
ProFoam
Generic Name
Radiological general body-part positioner
Model / Ref / Catalog
5018-A EUDAMED
ProFoam Wedge Inclination Kit GUDID
5018 GUDID
Primary DI / UDI-DI
07640178061781
Basic UDI-DI
764017806ProFoamTH
Direct Marketing DI
07640178061781
FDA Product Code
KXH
EMDN Code
V080302 Patient positioning medical cushions
GMDN Term
Radiological general body-part positioner
Device Class
Class I
Regulation Number
892.1830
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
5018-A
GUDID
ProFoam Wedge Inclination Kit

Other devices from Pearl Technology AG

See all devices from Pearl Technology AG →

Properties

  • Prescription Use
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No