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Ultrasonic Scaler

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

Ref MaxPiezo3Model MaxPiezo1, DS1, MaxPiezo2, MaxPiezo2+, DS2, DS2+, MaxPiezo3, MaxPiezo3+, DS3, DS3+, MaxPiezo5, MaxPiezo5+, DS5, DS5+, MaxPiezo6, MaxPiezo6+, DS6, DS6+, MaxPiezo7, MaxPiezo7+, DS7, DS7+

EMDN Z12119001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697156045MP3R6 Basic UDI-DIDate30 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
MaxPiezo1, DS1, MaxPiezo2, MaxPiezo2+, DS2, DS2+, MaxPiezo3, MaxPiezo3+, DS3, DS3+, MaxPiezo5, MaxPiezo5+, DS5, DS5+, MaxPiezo6, MaxPiezo6+, DS6, DS6+, MaxPiezo7, MaxPiezo7+, DS7, DS7+
Primary DI / UDI-DI
06971560451356
Basic UDI-DI
697156045MP3R6
Direct Marketing DI
06971560451356
EMDN Code
Z12119001 Tartar ablators
Device Class
Class IIa
Market of Registration
Germany

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 034031ed-f3b8-4199-922a-3983e3c401f0 61 fields · synced 23 Oct 2026