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Gauze products with X-ray detectable element

by Winner Medical Co., Ltd. United States EUDAMED

Ref 013383 EMDN M0201020202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number694109408360FJ Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Gauze products with X-ray detectable element
Model / Reference
013383
Primary DI / UDI-DI
16941094092926
Basic UDI-DI
694109408360FJ
EMDN Code
M0201020202 Cotton gauzes, folded, with x-ray detectable thread, non-sterile
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000005692
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Winner Medical Co., Ltd.

See all devices from Winner Medical Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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

Sources (1)

  • EUDAMED 16941094092926|694109408360FJ 61 fields · synced 25 Oct 2026