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Procedure pack for mini-invasive surgery and laparoscopic performances

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

Ref 105-127-SModel Procedure pack for mini-invasive surgery and laparoscopic performances

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8591527006000HPMCL3D Basic UDI-DI 08591527005675UDI-DIDate3 Sep 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Hitex pack
Model / Reference
Procedure pack for mini-invasive surgery and laparoscopic performances, 105-127-S
Primary DI / UDI-DI
08591527005675
Basic UDI-DI
8591527006000HPMCL3D
EMDN Code
T0202 Surgical procedural kits (excluding surgical instrument kits)
Device Class
Class IIb
Medical Purpose
Procedure pack for mini-invasive and laparoscopic performances provides a sterile and comprehensive pack of products necessary for the specific surgical procedures. It protects the patients and medical professionals; it helps 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 mini-invasive surgery and laparoscopy.

Manufacturer details

EUDAMED SRN
CZ-PR-000000561

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Properties

  • Sterile