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Sterile Gauze Swabs

by Xuchang Zhende Surgical Dressing Co., Ltd 56 variants

Ref MAC5112SA

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697240330SGP000001SR Basic UDI-DI 06977231816707UDI-DIDate19 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
gauze 13 threads in DOUBLE packaging sterile by ETO
Model / Reference
MAC5112SA
Primary DI / UDI-DI
06977231816707
Basic UDI-DI
697240330SGP000001SR
EMDN Code
M0201010101 Cotton gauze, cut, without x-ray detectable thread, sterile
Device Class
Class I
EU market of registration
Czechia

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

  • 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