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Wound drainage system - Wound drainage system

by BISMED, s.r.o. 9 variants

Ref 05.000.22.802Model Vacuum bottle for wound drainage Redon with tube; Podtlaková lahev pro drenáž Redon s hadicí

Active European Union

CE MDR

Valid until

25 Mar 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

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

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2025-MDR/QS-024/A Active

    Quality management system EU MDR

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

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, 05.000.22.802
Primary DI / UDI-DI
18594199790051
Basic UDI-DI
859419979REDONXH
EMDN Code
A0601010101 Drainage systems with redon type rigid container
Models / Variants
Wound drainage system
Device Class
Class IIa
EU 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

  • 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