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Procedure pack for multi-organ surgery

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

Ref 104-112-SModel Procedure pack for multi-organ surgery

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 Number8591527006000HPMOR4V Basic UDI-DI 08591527178249UDI-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  • Withdrawn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 multi-organ surgery, 104-112-S
Primary DI / UDI-DI
08591527178249
Basic UDI-DI
8591527006000HPMOR4V
EMDN Code
T0202 Surgical procedural kits (excluding surgical instrument kits)
Device Class
Class IIb
Medical Purpose
Procedure pack for multi-organ surgery provides a sterile and comprehensive pack of products necessary for the tissue extraction. It protects the patients and medical professionals; it helps to minimize the risk of transmission of microorganisms to the surgical wound as well as the extracted tissues.

Manufacturer details

EUDAMED SRN
CZ-PR-000000561

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Properties

  • Sterile