Skip to content

Dental Root Canal File

by Jining Orodeka Medical Equipment CO; LTD 98 variants

Ref Engine Use R-file012/03 21mm Engine Use R-file015/03 21mm Engine Use R-file017/04 21mmModel Engine Use R-file

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697284234EngineuserfileHX Basic UDI-DI 06972842345943UDI-DIDate4 Jun 2025RegisteredStatusActive

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  • Withdrawn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
Dental Root Canal File
Model / Reference
Engine Use R-file, Engine Use R-file012/03 21mm Engine Use R-file015/03 21mm Engine Use R-file017/04 21mm
Primary DI / UDI-DI
06972842345943
Basic UDI-DI
697284234EngineuserfileHX
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000034133
Authorised representative
ORODEKA S.R.L. IT-AR-000028475

Other devices from Jining Orodeka Medical Equipment CO; LTD

See all devices from Jining Orodeka Medical Equipment CO; LTD →

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