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Sterile Gauze Swabs

by Xuchang Zhende Surgical Dressing Co., Ltd China EUDAMED

Ref MAC5111S EMDN M0201010101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697240330SGP000001SR Basic UDI-DIDate19 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  • Withdrawn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 24 Oct 2026

Device Name
gauze 13 threads in DOUBLE packaging sterile by ETO
Model / Reference
MAC5111S
Primary DI / UDI-DI
06975629477233
Basic UDI-DI
697240330SGP000001SR
EMDN Code
M0201010101 Cotton gauze, cut, without x-ray detectable thread, sterile
Device Class
Class I
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
CN-MF-000009222
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Xuchang Zhende Surgical Dressing Co., Ltd.

See all devices from Xuchang Zhende Surgical Dressing 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 0c6ab480-87eb-4fdb-b2ef-b5c4256e1ecc 61 fields · synced 24 Oct 2026