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ceraPRIME® ZR+ Titan Opaque Powder A1 (50g)

by Elegant Dent Limited United Kingdom EUDAMED

Ref 280320Model Classic

EMDN Q01010199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05061090394382 Basic UDI-DIDate19 Oct 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 23 Oct 2026

Model / Reference
Classic, 280320
Primary DI / UDI-DI
05061090394382
Basic UDI-DI
B-05061090394382
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

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 05061090394382|B-05061090394382 61 fields · synced 23 Oct 2026