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Dental Root Canal Rotary File

by Foshan Asin Dental Equipment Co., Limited EUDAMED

Active European Union

Ref H-FilesModel 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  • Withdrawn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
06979929460360
Market of Registration
Austria

Manufacturer details

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

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