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Endo Files

by Foshan Linke Medical Instrument Co., Ltd China EUDAMED

Ref K6#Model K:6#,8#,10#,15#,20#,25#,30#,35#,40#,45#,50#,55#,60#,70#,80#,15/03,15/04,15/06,17/04,17/06, 20/04,20/06,25/04,25/06,30/04,30/06,35/04,35/06,40/04,50/05,13/02,16/02,19/02,30/08,17/08 H: 6#, 8#,10#,15#,20#,25#,30#,35#,40#, etc

EMDN Q010507

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697883683EF001N3 Basic UDI-DIDate9 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Endo Files
Model / Reference
K:6#, 8#, 10#, 15#, 20#, 25#, 30#, 35#, 40#, 45#, 50#, 55#, 60#, 70#, 80#, 15/03, 15/04, 15/06, 17/04, 17/06, 20/04, 20/06, 25/04, 25/06, 30/04, 30/06, 35/04, 35/06, 40/04, 50/05, 13/02, 16/02, 19/02, 30/08, 17/08 H: 6#, etc, K6#
Primary DI / UDI-DI
06978836830006
Basic UDI-DI
697883683EF001N3
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048246
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Foshan Linke Medical Instrument Co., Ltd

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 afd27761-ed6b-4bc9-b3d1-7dde15b66450 61 fields · synced 22 Oct 2026