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ceraPRIME® 3D Touch Dentine Structure EBL1 (4g)

by Elegant Dent Limited EUDAMED

Active European Union

Ref 371560Model Classic

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05061090397840 Basic UDI-DIDate19 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Classic, 371560
Primary DI / UDI-DI
05061090397840
Basic UDI-DI
B-05061090397840
EMDN Code
Q01010199 Dental restoration devices - other
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
UK-MF-000039640
Authorised representative
Elegant Dent Limited IE-AR-000037529

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See all devices from Elegant Dent Limited →

Properties

Show properties
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