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Stainless Steel C Files

by United Dental Changzhou

Ref SSCF002019010Model Stainless Steel C Files/Stainless Steel K Files/Stainless Steel H Files/Stainless Steel Reamers/M3-Micro Files (Micro Opener)/M3-Micro Files (Micro Shaper)/SS K-Files/SS Hedstroem Files/SS C plus Files/Z Micro-Opener/Z Micro-Shaper/C Plus

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697312285UDGEHI001K8 Basic UDI-DI 06942135214829UDI-DIDate20 May 2026RegisteredStatusActive

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  • Withdrawn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
Endodontic Hand Instruments
Model / Reference
Stainless Steel C Files/Stainless Steel K Files/Stainless Steel H Files/Stainless Steel Reamers/M3-Micro Files (Micro Opener)/M3-Micro Files (Micro Shaper)/SS K-Files/SS Hedstroem Files/SS C plus Files/Z Micro-Opener/Z Micro-Shaper/C Plus, SSCF002019010
Primary DI / UDI-DI
06942135214829
Basic UDI-DI
697312285UDGEHI001K8
EMDN Code
L159004 Endodontic rasps and files, reusable
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000018453
Authorised representative
Caretechion GmbH DE-AR-000005946

Related devices

Category: Manual endodontic file/rasp, reusable

Other devices from United Dental Changzhou

See all devices from United Dental Changzhou →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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