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dx direct aligner Bulk

by DETAX GmbH Germany EUDAMED

Ref 04746

EMDN Q010499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++EDET1065P Basic UDI-DIDate3 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
dx direct aligner
Model / Reference
04746
Primary DI / UDI-DI
+EDET047641
Basic UDI-DI
++EDET1065P
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000022666

Other devices from DETAX GmbH & Co. KG

See all devices from DETAX GmbH & Co. KG →

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 +EDET047641|++EDET1065P 61 fields · synced 25 Oct 2026