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Covers

by DINA – HITEX, spol. s r.o. EUDAMED

Active European Union

Ref 40-0218-PModel Camera covers, C-arm covers, Cord covers, Mayo covers, Other covers, Probe covers

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8591527000300INSP8 Basic UDI-DIDate2 Sep 2026RegisteredStatusActive

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  • Withdrawn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
Device covers
Model / Reference
Camera covers, C-arm covers, Cord covers, Mayo covers, Other covers, Probe covers, 40-0218-P
Primary DI / UDI-DI
08591527272312
Basic UDI-DI
8591527000300INSP8
EMDN Code
T030102 Cover sheaths, instruments and equipments
Device Class
Class I
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000000312

Other devices from DINA – HITEX, spol. s r.o.

See all devices from DINA – HITEX, spol. s r.o. →

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