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Shoe cover (Non-skid shoe cover, PP shoe cover, PE shoe cover, CPE shoe cover, PP+CPE shoe cover, PP boot cover, PE Boot cover, microporous boot cover)

by One Top Protective Products Co., Ltd.

Ref Non-skid Shoe cover 1805 LModel Non-skid Shoe cover 1805 L/XL/XXL PP shoe cover 1801 L/XL/XXL PE shoe cover 2809 L/XL/XXL CPE shoe cover 2802 L/XL/XXL etc

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 Number697867649SC01VW Basic UDI-DI 06978676491047UDI-DIDate11 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  • Withdrawn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
Shoe cover (Non-skid shoe cover, PP shoe cover, PE shoe cover, CPE shoe cover, PP+CPE shoe cover, PP boot cover, PE Boot cover, microporous boot cover)
Model / Reference
Non-skid Shoe cover 1805 L/XL/XXL PP shoe cover 1801 L/XL/XXL PE shoe cover 2809 L/XL/XXL CPE shoe cover 2802 L/XL/XXL etc, Non-skid Shoe cover 1805 L
Primary DI / UDI-DI
06978676491047
Basic UDI-DI
697867649SC01VW
EMDN Code
T0208 Shoe covers (excluding personal protective equipment - PPE)
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000023063
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