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Dental Root-Canal Instruments

by Shenzhen Perfect Medical Instruments Co., Ltd. China EUDAMED

Ref S1、S2、F1Model MTF、NTH、NTR、NTK、TG6、TH6、TH6-RI(HA定制) EMDN Q010507

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69590742NiTiHandfilesDR Basic UDI-DIDate17 Apr 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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
MTF、NTH、NTR、NTK、TG6、TH6、TH6-RI(HA定制), S1、S2、F1
Primary DI / UDI-DI
06941422625904
Basic UDI-DI
69590742NiTiHandfilesDR
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025529
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen Perfect Medical Instruments Co., Ltd.

See all devices from Shenzhen Perfect Medical Instruments Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 06941422625904|69590742NITIHANDFILESDR 61 fields · synced 25 Oct 2026