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Kera-Disc

by Eisenbacher Dentalwaren ED GmbH United States EUDAMED

Ref D10041116

EMDN Q010601

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++EDWACADCAMNEMQH Basic UDI-DIDate24 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Kera-Disc, Kera Line, Kera Soft-Disc
Model / Reference
D10041116
Primary DI / UDI-DI
++EDWAD100411161
Basic UDI-DI
++EDWACADCAMNEMQH
EMDN Code
Q010601 Dental alloys
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000008322

Other devices from Eisenbacher Dentalwaren Ed GmbH

See all devices from Eisenbacher Dentalwaren Ed GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • CMR Substance
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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 ++EDWAD100411161|++EDWACADCAMNEMQH 61 fields · synced 24 Oct 2026