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dialox

by Bioxal SAS France EUDAMED

Ref 70004085

EMDN D050103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426070938BIOXAL-BUDI-06MD Basic UDI-DIDate15 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000261580 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    6 Aug 2026
    Expires
    2 May 2029
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
70004085
Primary DI / UDI-DI
04260709380490
Basic UDI-DI
426070938BIOXAL-BUDI-06MD
EMDN Code
D050103 Peracetic acid for the disinfection of medical devices
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000481

Other devices from Bioxal SAS

See all devices from Bioxal SAS →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • 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 04260709380490|426070938BIOXAL-BUDI-06MD 61 fields · synced 24 Oct 2026