Skip to content

Dental Root-Canal Instruments

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

Ref 35/.04Model 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 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69590742NiTiRotaryVR Basic UDI-DIDate16 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  • Withdrawn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
EX-GOLD，TG6，EX-BLUE，EX，ET，RC，机用MTF，NXT(MTF PLUS)，TF4 GOLD，PX-ONE，GPH，etc., 35/.04
Primary DI / UDI-DI
06941422623061, 06941422626987, 06941422626185, 06941422626086, 06941422623306, 06941422623290, 06941422626796, 06941422620657, 06941422626567, 06941422626376, 06941422623313, 06941422623078, 06941422627175, 06941422620596, 06941422623054
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 (15)

  • EUDAMED da157fcc-b9cf-444f-830e-26da93b596c2 61 fields · synced 22 Oct 2026
  • EUDAMED 06941422626987|69590742NITIROTARYVR 61 fields · synced 7 Oct 2026
  • EUDAMED 06941422626185|69590742NITIROTARYVR 61 fields · synced 15 Oct 2026
  • EUDAMED 06941422626086|69590742NITIROTARYVR 61 fields · synced 20 Oct 2026
  • EUDAMED 06941422623306|69590742NITIROTARYVR 61 fields · synced 21 Oct 2026
  • EUDAMED 06941422623290|69590742NITIROTARYVR 61 fields · synced 21 Oct 2026
  • EUDAMED 06941422626796|69590742NITIROTARYVR 61 fields · synced 24 Oct 2026
  • EUDAMED 06941422620657|69590742NITIROTARYVR 61 fields · synced 24 Oct 2026
  • EUDAMED 06941422626567|69590742NITIROTARYVR 61 fields · synced 24 Oct 2026
  • EUDAMED 06941422626376|69590742NITIROTARYVR 61 fields · synced 24 Oct 2026
  • EUDAMED 06941422623313|69590742NITIROTARYVR 61 fields · synced 25 Oct 2026
  • EUDAMED 06941422623078|69590742NITIROTARYVR 61 fields · synced 25 Oct 2026
  • EUDAMED 06941422627175|69590742NITIROTARYVR 61 fields · synced 25 Oct 2026
  • EUDAMED 06941422620596|69590742NITIROTARYVR 61 fields · synced 25 Oct 2026
  • EUDAMED 06941422623054|69590742NITIROTARYVR 61 fields · synced 25 Oct 2026