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Surgical drapes

by DINA – HITEX, spol. s r.o. 515 variants

Ref AR-501-002-26-PModel Cardiovascular, ENT, General, Gynaecology, Incision, Laparoscopic, Mini-invasive, Multi-organ, Neurosurgery, Ophthalmology, Orthopaedic, Plastic, Stomatology, Thoracic, Urology, Vascular, Interventional radiology, EsySuit, Other

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8591527000100INSNE Basic UDI-DI 08591527363669UDI-DIDate2 Sep 2026RegisteredStatusActive

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  • Withdrawn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

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-501-002-26-P
Primary DI / UDI-DI
08591527363669
Basic UDI-DI
8591527000100INSNE
EMDN Code
T020102 Specialistic surgery drapes
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