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ProFile®.04

by Maillefer Instruments Holding Sàrl Switzerland EUDAMED

Ref A011N21802500

EMDN L159004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++J00310029E5 Basic UDI-DIDate2 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
Profile (RU, NiTi, Ro, MSA)
Model / Reference
A011N21802500
Primary DI / UDI-DI
J003A011N218025001
Basic UDI-DI
++J00310029E5
Unit of Use DI
J003A011N218025000
EMDN Code
L159004 Endodontic rasps and files, reusable
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
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 J003A011N218025001|++J00310029E5 61 fields · synced 25 Oct 2026