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Non sterile gauze swab with x-ray

by Yangzhou Super Union Import and Export Co., Ltd

Ref 15threads,10x20cm-12ply,with x-rayModel 11T,13T light,13T heavy,15T,17T,18T,20T,2.5~90cm*2.5~90cm--1~64ply,with x-ray

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697426559001084A Basic UDI-DI 06974265591358UDI-DIDate10 Aug 2026RegisteredStatusActive

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  • Withdrawn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
Non sterile gauze swab with x-ray
Model / Reference
11T, 13T light, 13T heavy, 15T, 17T, 18T, 20T, 2.5~90cm*2.5~90cm--1~64ply, with x-ray, 15threads, 10x20cm-12ply
Primary DI / UDI-DI
06974265591358
Basic UDI-DI
697426559001084A
EMDN Code
M0201020202 Cotton gauzes, folded, with x-ray detectable thread, non-sterile
Device Class
Class I
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000010954
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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