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ProFile® STERILE .04

by Maillefer Instruments Holding Sàrl Switzerland EUDAMED

Ref A011N23104503 EMDN Q010507

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++J00310028E3 Basic UDI-DIDate24 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Profile (SU, NiTi, Ro, MSA)
Model / Reference
A011N23104503
Primary DI / UDI-DI
J003A011N231045031
Basic UDI-DI
++J00310028E3
Unit of Use DI
J003A011N231045030
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CH-MF-000016301
Authorised representative
Dentsply DeTrey GmbH DE-AR-000005904

Other devices from Maillefer Instruments Holding Sàrl

See all devices from Maillefer Instruments Holding Sàrl →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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 J003A011N231045031|++J00310028E3 61 fields · synced 25 Oct 2026