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ENT procedure pack

by DINA - HITEX, spol. s r.o. EUDAMED

Active European Union

Ref 106-061-SModel ENT procedure pack

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8591527006000HPENT3N Basic UDI-DIDate3 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Hitex pack
Model / Reference
ENT procedure pack, 106-061-S
Primary DI / UDI-DI
08591527222553
Basic UDI-DI
8591527006000HPENT3N
EMDN Code
T0202 Surgical procedural kits (excluding surgical instrument kits)
Device Class
Class IIb
Medical Purpose
ENT procedure pack provides a sterile and comprehensive pack of products necessary for the specific surgical procedure. It protects the patients and medical professionals; it helps to minimize the risk of transmitting microorganisms into the surgical site, thereby reducing the risk of postoperative complications. It is designed to save time and increase efficiency through its layout. It is used in procedures for the modification of anatomical structures within ENT surgery.

Manufacturer details

EUDAMED SRN
CZ-PR-000000561

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Properties

  • Sterile