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pearltec ProFoam Table Mat 200x60x3 DSRGP

by Pearl Technology AG

Ref 1254-A

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

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 07640178061590UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640178061590 UDI-DI Date13 Dec 2022ListedStatusListed 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  • Withdrawn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 Table Mat 200x60x3 DSRGP EUDAMED
pearltec GUDID
Generic name
Radiological general body-part positioner
Device name
ProFoam
Model / Ref / Catalog
1254-A EUDAMED
ProFoam Table Mat 200x60x3 DSRGP GUDID
1254 GUDID
Primary DI / UDI-DI
07640178061590
Basic UDI-DI
764017806ProFoamTH
Direct marketing DI
07640178061590
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 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
1254-A
GUDID
ProFoam Table Mat 200x60x3 DSRGP

Related devices

Category: Radiological general body-part positioner

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)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No