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Ultrasonic Scaler Handpiece

by Guilin Refine Medical Instrument Co., Ltd. China EUDAMED

Ref HY-2LModel HP-3H, HP-5L, HS-7H, HS-7L, HY-2L EMDN Z12119006

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697156045USHTX Basic UDI-DIDate27 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
HP-3H, HP-5L, HS-7H, HS-7L, HY-2L
Primary DI / UDI-DI
06971560450076
Basic UDI-DI
697156045USHTX
Direct Marketing DI
06971560450076
EMDN Code
Z12119006 Dental cleaning/washing handpiece equipments
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000012204
Authorised representative
MedNet EC-REP C IIb GmbH DE-AR-000011194

Other devices from Guilin Refine Medical Instrument Co., Ltd.

See all devices from Guilin Refine Medical Instrument Co., Ltd. →

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 06971560450076|697156045USHTX 61 fields · synced 24 Oct 2026