Skip to content

Root Canal Files

by Shenzhen Superline Technology Co., Ltd. China EUDAMED

Ref BA1010402BModel K, H, Reamers, C

EMDN L159004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69448351ENDO01NS2X Basic UDI-DIDate29 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
K, H, Reamers, C, BA1010402B
Primary DI / UDI-DI
06944835157079
Basic UDI-DI
69448351ENDO01NS2X
Direct Marketing DI
06944835157079
EMDN Code
L159004 Endodontic rasps and files, reusable
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000027059
Authorised representative
Wellkang Ltd XI-AR-000001836

Related devices

Category: Manual endodontic file/rasp, reusable

Other devices from Shenzhen Superline Technology Co., Ltd.

See all devices from Shenzhen Superline Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED b121acfe-b686-42fa-8561-cd6603c77118 61 fields · synced 22 Oct 2026