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Dentizyme

by Quadralene Ltd United Kingdom EUDAMED

Ref DS160/6X2

EMDN D0801

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506047811DS160X9 Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Dentizyme
Model / Reference
DS160/6X2
Primary DI / UDI-DI
05060478110910
Basic UDI-DI
506047811DS160X9
EMDN Code
D0801 Enzymatic detergents for medical devices
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000016550
Authorised representative
MAQUET GmbH DE-AR-000009120

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 fa36aa17-e172-430b-ba40-424475d9437f 61 fields · synced 23 Oct 2026