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Pouches

by DINA – HITEX, spol. s r.o. EUDAMED

Active European Union

Ref 60-0103-SModel Arthroscopic pouches, Caesarotomy pouches, Gynaecological pouches, Neurosurgery pouches, Special pouches, Universal pouches

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8591527000400ISQC Basic UDI-DIDate3 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2023-MDR/QS-051 Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    10 Nov 2023
    Expires
    10 Nov 2028

Specification

EUDAMED

Model / Reference
Arthroscopic pouches, Caesarotomy pouches, Gynaecological pouches, Neurosurgery pouches, Special pouches, Universal pouches, 60-0103-S
Primary DI / UDI-DI
08591527088975
Basic UDI-DI
8591527000400ISQC
EMDN Code
A06030499 Intra-operation fluid collection devices - other
Device Class
Class I
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CZ-MF-000000312

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

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

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No