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Dental Root Canal Rotary File

by Foshan Asin Dental Equipment Co., Limited EUDAMED

Active European Union

Ref DS-BModel DS-H,DS-RB,DS-G,DS-B,M3-RB,M3-G,M3-B,D-Files,H-Files,K-Files,R-Files,S-Files,U-files,C-Files

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697992946DRCRF001QL Basic UDI-DIDate19 Mar 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Dental Root Canal Rotary File
Model / Reference
DS-H, DS-RB, DS-G, DS-B, M3-RB, M3-G, M3-B, D-Files, H-Files, K-Files, R-Files, S-Files, U-files, C-Files
Primary DI / UDI-DI
06979929460315
Basic UDI-DI
697992946DRCRF001QL
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000052628
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Foshan Asin Dental Equipment Co., Limited

See all devices from Foshan Asin Dental Equipment Co., Limited →

Properties

Show properties
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