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Nickel Titanium K-Files

by Shenzhen Rogin Medical Co., Ltd EUDAMED

Active European Union

Ref R-P.03.01-021-02-020-SR-000-00-00Model Nickel Titanium K-Files 21mm #20 6pcs/pack

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06972214516261 Basic UDI-DIDate23 Jul 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  • Withdrawn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
Nickel Titanium K-Files 21mm #20 6pcs/pack, R-P.03.01-021-02-020-SR-000-00-00
Primary DI / UDI-DI
06972214516261
Basic UDI-DI
B-06972214516261
EMDN Code
Q010501 Dental burs and abrasive disks, single-use
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000012192
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shenzhen Rogin Medical Co., Ltd

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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