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ProphyStar G3 - grün, grob

by Edenta Etablissement United States EUDAMED

Ref PSG3Model 16412

EMDN Q01010403

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000183128 Date27 Mar 2025IssuedStatusActive expires 26 Mar 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000183128 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    27 Mar 2025
    Expires
    26 Mar 2030

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Polierer / Arkansas
Model / Reference
16412, PSG3
Primary DI / UDI-DI
E312PSG31
Basic UDI-DI
++E31216412DU
Unit of Use DI
E312PSG3101
EMDN Code
Q01010403 Dental abrasive and polishing materials
Device Class
Class IIa
Market of Registration
Liechtenstein

Manufacturer details

EUDAMED SRN
LI-MF-000011937

Other devices from Edenta Etablissement

See all devices from Edenta Etablissement →

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 cbc2e90c-5026-4167-8c81-2fb55a47a349 61 fields · synced 22 Oct 2026