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Dental Root-Canal Instruments

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

Ref TG6,F5, TG6,F5 Model MTF、NTH、NTR、NTK、TG6、TH6、TH6-RI(HA定制)

EMDN Q010507

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69590742NiTiHandfilesDR Basic UDI-DIDate17 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
MTF、NTH、NTR、NTK、TG6、TH6、TH6-RI(HA定制), TG6, F5
Primary DI / UDI-DI
06959074267670, 06959074277099, 06959074267519, 06959074276931, 06959074277013, 06959074267359, 06959074267663, 06959074267342
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

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 (8)

  • EUDAMED c683d8a3-0af4-45d5-90dc-348218ce9f64-1 61 fields · synced 22 Oct 2026
  • EUDAMED 06959074277099|69590742NITIHANDFILESDR 61 fields · synced 10 Jul 2026
  • EUDAMED 06959074267519|69590742NITIHANDFILESDR 61 fields · synced 10 Jul 2026
  • EUDAMED 06959074276931|69590742NITIHANDFILESDR 61 fields · synced 12 Jul 2026
  • EUDAMED 06959074277013|69590742NITIHANDFILESDR 61 fields · synced 14 Jul 2026
  • EUDAMED 06959074267359|69590742NITIHANDFILESDR 61 fields · synced 21 Jul 2026
  • EUDAMED 06959074267663|69590742NITIHANDFILESDR 61 fields · synced 25 Jul 2026
  • EUDAMED 06959074267342|69590742NITIHANDFILESDR 61 fields · synced 31 Jul 2026