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Orafil Plus

by Prevest Denpro Limited India EUDAMED

Ref 11002Model Temporary Dental Material

EMDN Q0101010203

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-+D967110020. Basic UDI-DIDate9 Sep 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 25 Oct 2026

Model / Reference
Temporary Dental Material, 11002
Primary DI / UDI-DI
+D967110020.
Basic UDI-DI
B-+D967110020.
EMDN Code
Q0101010203 Temporary dental cements
Device Class
Class IIa
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
IN-MF-000011546
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Prevest Denpro Limited

See all devices from Prevest Denpro Limited →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED +D967110020.|B-+D967110020. 61 fields · synced 25 Oct 2026