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Dentitex x128

by Helago-Pharma GmbH & Co. KG Germany EUDAMED

Ref 900696Model Dentitex x128 DE / PL / PT / BE / FR / NL / ES

EMDN D0599

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-34002033006964 Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Dentitex x128 DE / PL / PT / BE / FR / NL / ES
Model / Reference
Dentitex x128 DE / PL / PT / BE / FR / NL / ES, 900696
Primary DI / UDI-DI
34002033006964
Basic UDI-DI
B-34002033006964
EMDN Code
D0599 Oxygen producers for disinfection of medical devices - other
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000004933

Other devices from Helago-Pharma GmbH & Co. KG

See all devices from Helago-Pharma GmbH & Co. KG →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED babcc6dd-9be1-4bc1-ad82-b1a30501650c 61 fields · synced 22 Oct 2026