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Surgical drapes

by DINA – HITEX, spol. s r.o. EUDAMED

Active European Union

Ref AR-102-012-17-PModel Cardiovascular, ENT, General, Gynaecology, Incision, Laparoscopic, Mini-invasive, Multi-organ, Neurosurgery, Ophthalmology, Orthopaedic, Plastic, Stomatology, Thoracic, Urology, Vascular, Interventional radiology, EsySuit, Other

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8591527000100INSNE 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  • Withdrawn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

Model / Reference
Cardiovascular, ENT, General, Gynaecology, Incision, Laparoscopic, Mini-invasive, Multi-organ, Neurosurgery, Ophthalmology, Orthopaedic, Plastic, Stomatology, Thoracic, Urology, Vascular, Interventional radiology, EsySuit, Other, AR-102-012-17-P
Primary DI / UDI-DI
08591527274293
Basic UDI-DI
8591527000100INSNE
EMDN Code
T020199 Surgical drapes - other
Device Class
Class I
Market of Registration
Ireland

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