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Procedure pack for general surgery

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

Active European Union

Ref 102-194-SModel Procedure pack for general surgery

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8591527006000HPGES33 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  • Withdrawn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
Procedure pack for general surgery, 102-194-S
Primary DI / UDI-DI
08591527195277
Basic UDI-DI
8591527006000HPGES33
EMDN Code
T0202 Surgical procedural kits (excluding surgical instrument kits)
Device Class
Class IIb
Medical Purpose
Procedure pack for general surgery 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 microbial transmission 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 general surgery.

Manufacturer details

EUDAMED SRN
CZ-PR-000000561

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Properties

  • Sterile