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Premium Non-Woven Sponges

by Crosstex International Inc 4 variants

Ref ENCNW4KModel Gauze and Sponges

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

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 10732224005208UDI-DIDate23 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10732224005208 UDI-DI Date17 Jul 2023ListedStatusListed 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Non-woven gauze pad
Model / Ref / Catalog
Gauze and Sponges, ENCNW4K
Primary DI / UDI-DI
10732224005208
Basic UDI-DI
0732224Gauze/SpongeJ6
Unit of Use DI
00732224005201
FDA Product Code
NAB
EMDN Code
M0202010102 Non-woven folded gauzes, without x-ray detectable thread, non-sterile
GMDN Term
Non-woven gauze pad
Device Class
Class I
Regulation Number
878.4014
Market of Registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Contains LatexEUDAMED
No
GUDID
Yes

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
  • Contains Latex NoEUDAMEDYesGUDID
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: 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