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K Files

by Shanwei Perfect Medical Instruments Co., Ltd. 340 variants

Ref A330 650 926 2802 035Model File Type K(SS304)/K Files、File Type H（SS304）/H Files、Reamer Type K(SS304)/Reamers etc

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697590932SSTHandfilesJ4 Basic UDI-DI 06942200940608UDI-DIDate18 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

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, A330 650 926 2802 035
Primary DI / UDI-DI
06942200940608
Basic UDI-DI
697590932SSTHandfilesJ4
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
EU 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

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