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Root Canal File, TriShade

by Guilin Kevin Peter Technology Co., Ltd. 2 variants

Ref /Model KP,DM: 1006, 1008, 12vt, 1302, 1403, 1506, 1602, 1603, 1606, 16vt, 1704, 1705, 1708, 1712, 1805, 1902, 2004, 2005, 2006, 2007, 2205, 2206, 2504, 2506, 2508, 3002, 3004, 3006, 3009, 3502, 3504, 3506, 4002, 4004, 4006, 4502, 4503, 4504, 5002, 5004, 6002, E

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69753843302YN Basic UDI-DI 16942751941076UDI-DIDate11 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  • Withdrawn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
Root Canal File
Model / Reference
KP, DM: 1006, 1008, 12vt, 1302, 1403, 1506, 1602, 1603, 1606, 16vt, 1704, 1705, 1708, 1712, 1805, 1902, 2004, 2005, 2006, 2007, 2205, 2206, 2504, 2506, 2508, 3002, 3004, 3006, 3009, 3502, 3504, 3506, 4002, 4004, 4006, 4502, 4503, 4504, 5002, 5004, 6002, E, /
Primary DI / UDI-DI
16942751941076
Basic UDI-DI
69753843302YN
EMDN Code
L159004 Endodontic rasps and files, reusable
Device Class
Class IIa
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000022934
Authorised representative
MedNet EC-REP C IIb GmbH DE-AR-000011194

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Properties

  • Reprocessed

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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