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Root Canal instruments

by Innovative Material and Devices, Inc China EUDAMED

Ref SK03021Model Root Canal Files-for hand

EMDN Q010507

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number695706705118-5232NM Basic UDI-DIDate1 Jul 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Root Canal Files
Model / Reference
Root Canal Files-for hand, SK03021
Primary DI / UDI-DI
06957067056249
Basic UDI-DI
695706705118-5232NM
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000002280
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Innovative Material and Devices, Inc

See all devices from Innovative Material and Devices, Inc →

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 e66e5c6a-cc18-434b-bb85-65129b2f1d87 61 fields · synced 24 Oct 2026