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Shoe Cover (Blue, Cpe)

by Zerkaya Teksti̇l Medi̇kal Gida İnşaat İth. İhr. San. Ve Ti̇c. Ltd. Şti̇.

Ref ZRK-411

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number868391107ZRK-411WT Basic UDI-DI 08683911070045UDI-DIDate29 Feb 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  • Withdrawn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

Device Name
Shoe Cover (Cpe)
Model / Reference
ZRK-411
Primary DI / UDI-DI
08683911070045
Basic UDI-DI
868391107ZRK-411WT
Direct Marketing DI
08683911070045
EMDN Code
T0208 Shoe covers (excluding personal protective equipment - PPE)
Device Class
Class I
EU market of registration
Portugal

Manufacturer details

EUDAMED SRN
TR-MF-000027572

From the manufacturer

Manufacturer's product page: CPE Shoe Cover

Other devices from Zerkaya Teksti̇l Medi̇kal Gida İnşaat İth. İhr. San. Ve Ti̇c. Ltd. Şti̇.

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