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Shoe covers

by Thankmed Healthcare Import&Export Company Limited EUDAMED

Active European Union

Ref E-103Model SC-101,SC-102,SC-501,SC-502,SC-503,SC-801 E-101,E-102,E-103,E-104,E-105

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697564138shoecover511W6 Basic UDI-DIDate10 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Shoe covers
Model / Reference
SC-101, SC-102, SC-501, SC-502, SC-503, SC-801 E-101, E-102, E-103, E-104, E-105
Primary DI / UDI-DI
06975641385127
Basic UDI-DI
697564138shoecover511W6
EMDN Code
T0208 Shoe covers (excluding personal protective equipment - PPE)
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000008478
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Thankmed Healthcare Import&Export Company Limited

See all devices from Thankmed Healthcare Import&Export Company Limited →

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