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Dental Root-Canal Instruments

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

Ref TF4 GOLD,20/.07Model EX-GOLD，TG6，EX-BLUE，EX，ET，RC，机用MTF，NXT(MTF PLUS)，TF4 GOLD，PX-ONE，GPH，etc.

EMDN Q010507

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69590742NiTiRotaryVR Basic UDI-DIDate16 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
EX-GOLD，TG6，EX-BLUE，EX，ET，RC，机用MTF，NXT(MTF PLUS)，TF4 GOLD，PX-ONE，GPH，etc., TF4 GOLD, 20/.07
Primary DI / UDI-DI
06941422614809
Basic UDI-DI
69590742NiTiRotaryVR
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 8b997810-70f0-4ee4-a6f6-22e136a60020-1 61 fields · synced 22 Oct 2026