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Rotary Endo File

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

Ref /Model 2S+

EMDN L159004

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970602033994 Basic UDI-DIDate10 Jul 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 22 Oct 2026

Model / Reference
2S+, /
Primary DI / UDI-DI
06970602033994
Basic UDI-DI
B-06970602033994
EMDN Code
L159004 Endodontic rasps and files, reusable
Device Class
Class IIa
Market of Registration
Czechia

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 a5b33400-ede9-4f8d-aeb5-baec9ed2d672 61 fields · synced 22 Oct 2026