Skip to content

ProFile® .06

by Maillefer Instruments Holding Sàrl 21 variants

Ref A034521803500

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++J00310029E5 Basic UDI-DI J003A0345218035001UDI-DIDate2 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Profile (RU, NiTi, Ro, MSA)
Model / Reference
A034521803500
Primary DI / UDI-DI
J003A0345218035001
Basic UDI-DI
++J00310029E5
Unit of Use DI
J003A0345218035000
EMDN Code
L159004 Endodontic rasps and files, reusable
Device Class
Class IIa
EU 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

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