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Bite Wing-Ease Barrier Sleeves

by Crosstex International Inc 2 variants

Ref BWELModel Dental X-Ray Comfort Cushions

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0732224ImagingComfortPU Basic UDI-DI 10732224002986UDI-DIDate28 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10732224002986 UDI-DI Date29 Sep 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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

Generic Name
Dental x-ray film holder, single-use
Model / Reference
Dental X-Ray Comfort Cushions, BWEL
Primary DI / UDI-DI
10732224002986
Basic UDI-DI
0732224ImagingComfortPU
Unit of Use DI
00732224002989
510(k) Number
FDA Product Code
EGZ
EMDN Code
Z1103040102 Equipment for digital endoral radiology
GMDN Term
Dental x-ray film holder, single-use
Device Class
Class I
Regulation Number
872.1905
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000009642
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Dental digital imaging sensor, intraoral

Other devices from Crosstex International, Inc.

See all devices from Crosstex International, Inc. →

Properties

  • Single Use
  • Lot / Batch Number

Other properties (22)

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