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Shoe cover

by Xiantao Chenguang Protection Commodity Co., Ltd. EUDAMED

Active European Union

Ref 161104X, 161548X, 161540XModel SC001

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697478283SC001NN Basic UDI-DIDate27 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

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

Specification

EUDAMED

Model / Reference
SC001, 161104X, 161548X, 161540X
Primary DI / UDI-DI
06974782830909, 06974782830992, 06974782830718
Basic UDI-DI
697478283SC001NN
Direct Marketing DI
06974782830909
06974782830992
06974782830718
EMDN Code
T0208 Shoe covers (excluding personal protective equipment - PPE)
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000025794
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Xiantao Chenguang Protection Commodity Co., Ltd.

See all devices from Xiantao Chenguang Protection Commodity 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