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K Files

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

Ref SA3306509262802045、SA3306509262802050、SA3306509262802055、SA3306509262802060、SA3306509262802070、SA3306509262802080Model File Type K(SS304)/K Files、File Type H（SS304）/H Files、Reamer Type K(SS304)/Reamers etc

EMDN Q010507

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697590932SSTHandfilesJ4 Basic UDI-DIDate18 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Dental Root-Canal Instruments
Model / Reference
File Type K(SS304)/K Files、File Type H（SS304）/H Files、Reamer Type K(SS304)/Reamers etc, SA3306509262802045、SA3306509262802050、SA3306509262802055、SA3306509262802060、SA3306509262802070、SA3306509262802080
Primary DI / UDI-DI
06942200961917
Basic UDI-DI
697590932SSTHandfilesJ4
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-000033003
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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

See all devices from Shanwei 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 7bfd1618-3298-4ab4-b301-a81658cb3611 61 fields · synced 22 Oct 2026