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Shoe Cover

by Vandl Biotechnology Inc

Ref YL-95012

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 Number++G546YL95012TT Basic UDI-DI Date13 Apr 2024RegisteredStatusActive

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  • Withdrawn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

Trade Name
VANDL C.P.E. Shoe Cover
Device Name
Shoe Cover
Model / Reference
YL-95012
Primary DI / UDI-DI
*+G546YL950120F*, ++G546VANDL0057AK, +G546VANDL0057AK0
Basic UDI-DI
++G546YL95012TT, ++G54600572T
EMDN Code
T0208 Shoe covers (excluding personal protective equipment - PPE)
Device Class
Class I
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000037509
Authorised representative
MB Global Service B.V. NL-AR-000037296

Other devices from Vandl Biotechnology Inc

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Properties

  • Contains Latex NoEUDAMEDYesEUDAMED

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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