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Fluorotop APF

by Prevest Denpro Limited India EUDAMED

Ref 80005Model Auxiliary Material

EMDN Q010199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++D967AMTF0322 Basic UDI-DIDate1 Oct 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
Auxiliary Material
Model / Reference
Auxiliary Material, 80005
Primary DI / UDI-DI
+D9678000503
Basic UDI-DI
++D967AMTF0322
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
Device Class
Class I
Market of Registration
Romania

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 (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 +D9678000503|++D967AMTF0322 61 fields · synced 25 Oct 2026