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Wound drainage system; Drenážní systém pro hojení ran

by BISMED, s.r.o. Czechia EUDAMED

Ref 99.000.22.802Model Vacuum bottle for wound drainage Redon with tube; Podtlaková lahev pro drenáž Redon s hadicí EMDN A0601010101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2025-MDR/QS-024/A Date3 Mar 2026IssuedStatusActive expires 25 Mar 2030

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  • Withdrawn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)
  • 2025-MDR/QS-024/A Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    3 Mar 2026
    Expires
    25 Mar 2030

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Wound drainage system; Drenážní systém pro hojení ran
Model / Reference
Vacuum bottle for wound drainage Redon with tube, Podtlaková lahev pro drenáž Redon s hadicí, 99.000.22.802
Primary DI / UDI-DI
18594199790204
Basic UDI-DI
859419979REDONXH
EMDN Code
A0601010101 Drainage systems with redon type rigid container
Device Class
Class IIa
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000040871

Other devices from BISMED, s.r.o.

See all devices from BISMED, s.r.o. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 1f88d63d-db06-4754-90fd-59add550ea44 61 fields · synced 24 Oct 2026