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Rotary Endo File

by Chengdu Sani Medical Equipment Co., Ltd. China EUDAMED

Ref /Model 4S EMDN L159004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970602030733 Basic UDI-DIDate9 Jul 2024RegisteredStatusActive

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  • Withdrawn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 · synced 22 Oct 2026

Model / Reference
4S, /
Primary DI / UDI-DI
06970602030733
Basic UDI-DI
B-06970602030733
EMDN Code
L159004 Endodontic rasps and files, reusable
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000011715
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Chengdu Sani Medical Equipment Co., Ltd

See all devices from Chengdu Sani Medical Equipment 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 3b78ed09-012b-4a8e-aac9-26ffb0be533b 61 fields · synced 22 Oct 2026