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NiTi Engine K Files, Assorted 15#/.02, 20#/.02, 25#/.02;21mm，6pcs/pk

by Innovative Material and Devices, Inc

Ref NTK00321

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 Number693694921600-6668V5 Basic UDI-DI 06937107157570UDI-DIDate3 Sep 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  • Withdrawn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
NiTi Engine K Files, Assorted 15#/.02, 20#/.02, 25#/.02;21mm，6pcs/pk
Model / Reference
NTK00321
Primary DI / UDI-DI
06937107157570
Basic UDI-DI
693694921600-6668V5
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Models / Variants
Device Class
Class IIa
EU 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

  • Reprocessed

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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