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Gauze Products without X-ray Detectable Element

by Winner Medical Co., Ltd. United States EUDAMED

Ref 19721216Model Gauze Swabs/Sponges without X-ray Detectable Element / Gauze Balls without X-ray Detectable Element

EMDN M0201020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number694109408333FF Basic UDI-DIDate25 Oct 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Gauze Products without X-ray Detectable Element
Model / Reference
Gauze Swabs/Sponges without X-ray Detectable Element / Gauze Balls without X-ray Detectable Element, 19721216
Primary DI / UDI-DI
16942327039305
Basic UDI-DI
694109408333FF
EMDN Code
M0201020101 Cotton gauzes, folded, without x-ray detectable thread, sterile
Device Class
Class I
Market of Registration
Germany

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
  • Sterile
Other properties (12)
  • 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 16942327039305|694109408333FF 61 fields · synced 25 Oct 2026