Skip to content

Orthopaedics procedure pack

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

Active European Union

Ref 301-233-SModel Orthopaedic procedure pack

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8591527006000HPORT5L 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  • Withdrawn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
Orthopaedic procedure pack, 301-233-S
Primary DI / UDI-DI
08591527224151
Basic UDI-DI
8591527006000HPORT5L
EMDN Code
T0202 Surgical procedural kits (excluding surgical instrument kits)
Device Class
Class IIb
Medical Purpose
Orthopaedic procedure pack provides a sterile and comprehensive pack of products necessary for the specific surgical procedures. 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 orthopaedics.

Manufacturer details

EUDAMED SRN
CZ-PR-000000561

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

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

Properties

  • Sterile