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Disposable Shoes Cover

by Hubei Medwear Protective Products Co., Ltd

Ref 16*41Model 16*41CM 16*45CM

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 Number697654158scover45 Basic UDI-DI 06976541580063UDI-DIDate7 Jul 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  • Withdrawn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

Device Name
Disposable Shoes Cover
Model / Reference
16*41CM 16*45CM, 16*41
Primary DI / UDI-DI
06976541580063
Basic UDI-DI
697654158scover45
EMDN Code
T0208 Shoe covers (excluding personal protective equipment - PPE)
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000002182
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Hubei Medwear Protective Products 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