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Nonsterile Gauze Bandages

by Kingstar Medical (Xianning) Co., LTD 16 variants

Ref C005014

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Overview

Nonsterile gauze bandages are medical devices used for surgical procedures and wound care. These reusable, sterile gauze products are designed to provide absorbency, stability, and hygiene during medical operations. They come in standard sizes and can be used to cover wounds, apply pressure, or secure sutures.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6971872201081000MZ Basic UDI-DI 66971872205298UDI-DIDate3 Apr 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
C005014
Primary DI / UDI-DI
66971872205298
Basic UDI-DI
6971872201081000MZ
EMDN Code
M0201010102 Cotton gauzes, cut, without x-ray detectable thread, non-sterile
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000006015
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Kingstar Medical (Xianning) Co., Ltd.

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Properties

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