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Absorbent Cotton Gauze(Gauze Roll/Bandage)

by Xinxiang Tianhong Medical Device Co., Ltd.

Ref Yarn 21 xMesh 19*15 xWidth 90cmModel Yarn(5-100)xMesh(1-500)xWidth(1cm-500cm), other sizes customizable upon request

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69354722COTTONGAUZEMR Basic UDI-DI 06935472200600UDI-DIDate12 Jun 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Absorbent Cotton Gauze(Gauze Roll/Bandage)
Model / Reference
Yarn(5-100)xMesh(1-500)xWidth(1cm-500cm), other sizes customizable upon request, Yarn 21 xMesh 19*15 xWidth 90cm
Primary DI / UDI-DI
06935472200600
Basic UDI-DI
69354722COTTONGAUZEMR
EMDN Code
M020107 Cotton gauzes in rolls
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000009219
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Xinxiang Tianhong Medical Device Co., Ltd.

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