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Dental Root-Canal Instruments

by Shenzhen FeiHuan Medical Instruments Co., Ltd. 1,000+ variants

Ref #15、#20、#25、#30、#35、#40Model SSK，SSH，SSK-F，SSC，SSC-V，SSR，SSD，ETC., DH GOLD,DK,ET,ET GOLD,EX,GPH,GPH GOLD,HW GOLD,MG3 BILE,ETC., MTF,NTH,NTR,NTK,TG6,ETC., HDP,NTP,SSP,SSS,NTS,ETC.

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69415761HandfilesK2 Basic UDI-DI Date13 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
SSK，SSH，SSK-F，SSC，SSC-V，SSR，SSD，ETC., #15、#20、#25、#30、#35、#40, DH GOLD, DK, ET, ET GOLD, EX, GPH, GPH GOLD, HW GOLD, MG3 BILE, ETC., MTF, NTH, NTR, NTK, TG6, HDP, NTP, SSP, SSS, NTS
Primary DI / UDI-DI
06971745843730, 06941576104102, 06941576133768, 06941576133164, 06941576113364, 06941576112169, 06941576103303, 06941576132365, 06941576113166, 06941576102856, 06941576136561, 06941576113562, 06941576131368, 06941576117560, 06941576137568, 06941576116167, 06941576112367, 06971745843662, 06941576111766, 06941576111162, 06941576103150, 06941576137766, 06941576103006, 06941576131764, 06941576111568, 06941576137360, 06941576111360, 06941576137162, 06941576113760, 06941576117164, 06941576131566, 06941576116563, 06941576133362, 06941576116365, 06941576133560, 06941576117768, 06941576131160, 06941576117362, 06941576136769, 06941576132167, 06941576112565, 06941576132563, 06971745843525, 06941576112763, 06941576136165, 06941576116761, 06971745843594, 06941576136363, 06941576132761
Basic UDI-DI
69415761HandfilesK2, 69415761NiTiRotaryQE, 69415761NiTiHandfiles78, 69415761NiTiCompactorFD
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000041454
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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