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H-Files Flex

by FKG Dentaire Sàrl Switzerland EUDAMED

Ref 01.553.25.015.CG EMDN L159004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7640142410301029G Basic UDI-DIDate21 Oct 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Sterile and non sterile reusable hand tools for root canal preparation during endodontic treatment
Model / Reference
01.553.25.015.CG
Primary DI / UDI-DI
07640142417071
Basic UDI-DI
7640142410301029G
EMDN Code
L159004 Endodontic rasps and files, reusable
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000017925
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Manual endodontic file/rasp, reusable

Other devices from FKG Dentaire Sàrl

See all devices from FKG Dentaire Sàrl →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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 97df97e1-f4a4-4c97-91af-6fc283f379c1 61 fields · synced 24 Oct 2026