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Dental File

by Swordental Co., Ltd China EUDAMED

Ref 6#Model K/H/R/S/P， D/TC/U，S-R，C，G drill，P drill，B1，B2，M，25#/30#/40#/35#，0#/00#/000#/1#/2#/3#/4#/5#/6#

EMDN L159019

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697867861WDF42 Basic UDI-DIDate5 Jan 2026RegisteredStatusActive

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
Dental File
Model / Reference
K/H/R/S/P， D/TC/U，S-R，C，G drill，P drill，B1，B2，M，25#/30#/40#/35#，0#/00#/000#/1#/2#/3#/4#/5#/6#, 6#
Primary DI / UDI-DI
06978678610903
Basic UDI-DI
697867861WDF42
EMDN Code
L159019 Dental finishing rasps and files, reusable
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000051060
Authorised representative
HyperCert Limited B.V. NL-AR-000047746

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 ae016a56-f438-4e0f-bc7f-9de28eddcc7b 61 fields · synced 22 Oct 2026