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H Files

by Shandong Hengfeng Kerui Medical Equipment Co., Ltd China EUDAMED

Ref SSH 2102 055Model SST Hand Files List of models: SSK 2102 006, SSK 2502 006, SSK 2802 006, SSK 3102 006, SSK 2102 008, SSK 2502 008, SSK 2802 008, SSK 3102 008, SSK 2102 010, SSK 2502 010,SSK 2802 010,etc

EMDN Q01010299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69363400DRCI001H3 Basic UDI-DIDate19 May 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

Device Name
Dental Root Canal Instruments
Model / Reference
SST Hand Files List of models: SSK 2102 006, SSK 2502 006, SSK 2802 006, SSK 3102 006, SSK 2102 008, SSK 2502 008, SSK 2802 008, SSK 3102 008, SSK 2102 010, SSK 2502 010, SSK 2802 010, etc, SSH 2102 055
Primary DI / UDI-DI
06936340004429
Basic UDI-DI
69363400DRCI001H3
EMDN Code
Q01010299 Root canal filling devices - other
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000042567
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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 1b78bf12-eff2-40d3-bfe4-b5276b599161 61 fields · synced 22 Oct 2026