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Limas K

by Shenzhen Denco Medical Co., Ltd. China EUDAMED

Ref ZKFILE2106Model Limas K 21mm 06 (6 uds.)

EMDN Q030311

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06975718050897 Basic UDI-DIDate2 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Dental Root Canal Instruments
Model / Reference
Limas K 21mm 06 (6 uds.), ZKFILE2106
Primary DI / UDI-DI
06975718050897
Basic UDI-DI
B-06975718050897
EMDN Code
Q030311 ENT surgery rasps and files, single-use
Device Class
Class IIa
Market of Registration
Spain

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 & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • 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

Sources (1)

  • EUDAMED 6418df4c-cd47-4962-8f91-7fdfc2ddef51 61 fields · synced 24 Oct 2026