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Advantage Plus Cotton Tipped Applicators

by Crosstex International Inc 2 variants

Ref H3ACModel Gauze and Sponges

Withdrawn Withdrawn in European Union.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Was authorized under CE MDR, withdrawn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Withdrawn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, 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 Number0732224Gauze/SpongeJ6 Basic UDI-DI 10732224003549UDI-DIDate23 May 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number10732224003549 UDI-DI Date19 Aug 2022ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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  • European Union CE/MDR Withdrawn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
General-purpose absorbent tip applicator/swab, single-use
Model / Reference
Gauze and Sponges, H3AC
Primary DI / UDI-DI
10732224003549
Basic UDI-DI
0732224Gauze/SpongeJ6
Unit of Use DI
00732224003542
FDA Product Code
KXF
EMDN Code
Q019006 Dental material application tips and brushes, single-use
GMDN Term
General-purpose absorbent tip applicator/swab, single-use
Device Class
Class I
Regulation Number
880.6025
Market of Registration
Germany
GUDID distribution status
Not in Commercial Distribution

Manufacturer details

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

Other devices from Crosstex International, Inc.

See all devices from Crosstex International, Inc. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No