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pearltec ProFoam Head Support

by Pearl Technology AG

Part of a family of 63 devices: see the family page

Ref 1279-A

pearltec ProFoam Head Support (1279) is a Class I device made by Pearl Technology AG, registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI 764017806ProFoamTH) and listed in FDA GUDID since 28 Jul 2025 (UDI-DI 07640178061811), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764017806ProFoamTH Basic UDI-DI 07640178061811UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640178061811 UDI-DI Date28 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 764017806ProFoamTH registered 3 Sep 2026 Active
  • FDA GUDID UDI-DI 07640178061811 listed 28 Jul 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07640178061811
  2. Registered EUDAMED 764017806ProFoamTH

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  • Withdrawn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 Head Support EUDAMED
pearltec GUDID
Generic name
Radiological headrest
Device name
ProFoam
Model / Ref / Catalog
1279-A EUDAMED
ProFoam Head Support GUDID
1279 GUDID
Primary DI / UDI-DI
07640178061811
Basic UDI-DI
764017806ProFoamTH
Direct marketing DI
07640178061811
FDA product code
IWY
EMDN code
V080302 Patient positioning medical cushions
GMDN term
Radiological headrest
Device class
Class I
Regulation number
892.1920
EU registration type
Standard device
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
1279-A
GUDID
ProFoam Head Support

Related devices

Category: Radiological headrest

Similar devices in this category

Other devices filed under MEDICAL CUSHIONS.

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 (21, all answered No)