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Incision films

by DINA – HITEX, spol. s r.o. 2 variants

Ref 76-0118-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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8591527000100INSNE Basic UDI-DI 08591527124703UDI-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  • Withdrawn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

Device Name
Surgical drapes
Model / Reference
Cardiovascular, ENT, General, Gynaecology, Incision, Laparoscopic, Mini-invasive, Multi-organ, Neurosurgery, Ophthalmology, Orthopaedic, Plastic, Stomatology, Thoracic, Urology, Vascular, Interventional radiology, EsySuit, Other, 76-0118-P
Primary DI / UDI-DI
08591527124703
Basic UDI-DI
8591527000100INSNE
EMDN Code
T02010101 Incision drapes, without antibacterial agent
Device Class
Class I
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000000312

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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