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NITI K-Files

by Shenzhen Denco Medical Co., Ltd. EUDAMED

Active European Union

Ref D-P.03.01-028-02-0A1-SR-000-00-00Model NITI K-Files 28mm #45-80 6pcs/pack

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970514914503 Basic UDI-DIDate14 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
NITI K-Files 28mm #45-80 6pcs/pack, D-P.03.01-028-02-0A1-SR-000-00-00
Primary DI / UDI-DI
06970514914503
Basic UDI-DI
B-06970514914503
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000014271
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from Shenzhen Denco Medical Co., Ltd.

See all devices from Shenzhen Denco Medical Co., Ltd. →

Properties

Show properties
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No