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Dental Root Canal File

by Jining Orodeka Medical Equipment CO; LTD 98 variants

Ref Engine Use R-file030/04 25mm, Engine Use H-file Rc025/06 21mm, Engine Use R-file035 04 21mm, Engine Use R-file025/04 28mm, Engine Use R-file050/04 21mm, Engine Use R-file012/03 28mm, Engine Use R-file 015/08 19mm 012/03 28mm 017/045 28mm 020/04 28mm 025/04 28mm, Engine Use R-file025/04 25mm 030/04 25mm 035/04 25mm 040/04 25mm, Engine UseK-file012/03 21mm, Engine Use R-file015/08 19mm Engine Use R-file015/03 21mm Engine Use R-file020/04 21mm Engine Use R-file025/04 21mm, Engine Use H-file Rc025/06 25mm Engine Use H-file Rc050/04 25mm Engine Use H-file Rc040/05 25mm, Engine Use R-file015/08 19mm Engine Use R-file015/03 28mm Engine Use R-file020/04 28mm Engine Use R-file025/04 28mm, Engine Use R-file015/03 25mm, Engine Use H-file 025/07 19mm Engine Use H-file 020/06 25mm Engine Use R-file 030/02 25mm, Engine Use R-file017/045 21mm, Engine Use H-file Rc040/05 28mm, Engine Use R-file050/04 25mm, Engine Use R-file040 05 25mm, Engine Use R-file025/04 31mm, Engine Use R-file015/08 19mm 012/03 31mm 017/045 31mm 022/055 31mm 025/06 31mm, Engine Use R-file025/04 25mm, Engine Use H-file Rc040/05 21mm, Engine UseK-file 012/03 25mm, Engine Use R-file030/04 25mm Engine Use R-file035/04 25mm Engine Use R-file040/04 25mm Engine Use R-file045/04 25mm, Engine Use R-file030/09 16mm Engine Use R-file025/08 18mm Engine Use R-file020/07 22mm, Engine Use R-file030/04 31mm, Engine Use R-file015/08 19mm, Engine Use R-file020/04 31mm, Engine Use R-file015/08 19mm Engine Use R-file015/03 31mm Engine Use R-file020/04 31mm Engine Use R-file025/06 31mm, Engine Use R-file020/05 31mm, Engine Use H-file Rc050/04 25mm, Engine Use H-file Rc025/04 31mm, Engine Use R-file045/04 31mm, Engine Use R-file020/06 25mm, Engine Use R-file025 06 28mm Engine Use R-file050 04 28mm Engine Use R-file040 05 28mm, Engine Use R-file040/06 25mm, Engine Use R-file020/05 21mm, Engine Use R-file035/06 25mm, Engine Use R - file035/04 28mm, Engine Use R-file022/055 21mm, Engine Use R-file055/04 21mm, Engine Use R-file020/05 25mm, Engine Use R-file015/03 31mm, Engine Use R-file022/055 31mm, Engine Use R-file050/04 31mm, Engine Use R-file030/04 16mm, Engine Use R-file050 04 21mm, Engine Use R-file012/03 25mm Engine Use R-file015/03 25mm Engine Use R-file017/04 25mm, Engine Use R-file030/06 25mm, Engine Use R-file040/04 31mm, Engine Use R-file055/04 31mmModel Engine Use R-file, Engine Use H-file, Engine Use K-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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697284234EngineuserfileHX Basic UDI-DI Date4 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-file030/04 25mm, Engine Use H-file, Engine Use H-file Rc025/06 21mm, Engine Use R-file035 04 21mm, Engine Use R-file025/04 28mm, Engine Use R-file050/04 21mm, Engine Use R-file012/03 28mm, Engine Use R-file 015/08 19mm 012/03 28mm 017/045 28mm 020/04 28mm 025/04 28mm, Engine Use R-file025/04 25mm 030/04 25mm 035/04 25mm 040/04 25mm, Engine Use K-file, Engine UseK-file012/03 21mm, Engine Use R-file015/08 19mm Engine Use R-file015/03 21mm Engine Use R-file020/04 21mm Engine Use R-file025/04 21mm, Engine Use H-file Rc025/06 25mm Engine Use H-file Rc050/04 25mm Engine Use H-file Rc040/05 25mm, Engine Use R-file015/08 19mm Engine Use R-file015/03 28mm Engine Use R-file020/04 28mm Engine Use R-file025/04 28mm, Engine Use R-file015/03 25mm, Engine Use H-file 025/07 19mm Engine Use H-file 020/06 25mm Engine Use R-file 030/02 25mm, Engine Use R-file017/045 21mm, Engine Use H-file Rc040/05 28mm, Engine Use R-file050/04 25mm, Engine Use R-file040 05 25mm, Engine Use R-file025/04 31mm, Engine Use R-file015/08 19mm 012/03 31mm 017/045 31mm 022/055 31mm 025/06 31mm, Engine Use R-file025/04 25mm, Engine Use H-file Rc040/05 21mm, Engine UseK-file 012/03 25mm, Engine Use R-file030/04 25mm Engine Use R-file035/04 25mm Engine Use R-file040/04 25mm Engine Use R-file045/04 25mm, Engine Use R-file030/09 16mm Engine Use R-file025/08 18mm Engine Use R-file020/07 22mm, Engine Use R-file030/04 31mm, Engine Use R-file015/08 19mm, Engine Use R-file020/04 31mm, Engine Use R-file015/08 19mm Engine Use R-file015/03 31mm Engine Use R-file020/04 31mm Engine Use R-file025/06 31mm, Engine Use R-file020/05 31mm, Engine Use H-file Rc050/04 25mm, Engine Use H-file Rc025/04 31mm, Engine Use R-file045/04 31mm, Engine Use R-file020/06 25mm, Engine Use R-file025 06 28mm Engine Use R-file050 04 28mm Engine Use R-file040 05 28mm, Engine Use R-file040/06 25mm, Engine Use R-file020/05 21mm, Engine Use R-file035/06 25mm, Engine Use R - file035/04 28mm, Engine Use R-file022/055 21mm, Engine Use R-file055/04 21mm, Engine Use R-file020/05 25mm, Engine Use R-file015/03 31mm, Engine Use R-file022/055 31mm, Engine Use R-file050/04 31mm, Engine Use R-file030/04 16mm, Engine Use R-file050 04 21mm, Engine Use R-file012/03 25mm Engine Use R-file015/03 25mm Engine Use R-file017/04 25mm, Engine Use R-file030/06 25mm, Engine Use R-file040/04 31mm, Engine Use R-file055/04 31mm
Primary DI / UDI-DI
06972842343178, 06972842344472, 06972842344793, 06972842343000, 06972842341471, 06972842344281, 06972842340573, 06972842340696, 06972842340542, 06972842341648, 06972842344625, 06972842344120, 06972842341020, 06972842340597, 06972842344304, 06972842344595, 06972842341488, 06972842344885, 06972842343017, 06972842344427, 06972842341662, 06972842344571, 06972842340634, 06972842340726, 06972842344434, 06972842343192, 06972842341372, 06972842341082, 06972842344212, 06972842341242, 06972842344540, 06972842345028, 06972842343239, 06972842341518, 06972842344939, 06972842343109, 06972842341211, 06972842343093, 06972842341150, 06972842344342, 06972842343246, 06972842341228, 06972842341044, 06972842344380, 06972842343048, 06972842344151, 06972842344830, 06972842340566, 06972842341266, 06972842343024, 06972842343277
Basic UDI-DI
697284234EngineuserfileHX, 697284234EngineusehfileEH, 697284234EngineusekfileFJ
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

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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