Skip to content

Fresa PRIME SM Ø 3, 3 h 8, 5

by Prodent Italia S.r.l. Italy EUDAMED

Ref 0803155

EMDN Q010399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805214171300A019Z Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030042-04 Issued

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    20 Jun 2026
    Expires
    26 Sep 2028

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Strumenti di Taglio in Acciaio / Steel Cutting Tools
Model / Reference
0803155
Primary DI / UDI-DI
08056284293685
Basic UDI-DI
805214171300A019Z
EMDN Code
Q010399 Surgical dental devices - other
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000022007

Other devices from Prodent Italia S.r.l.

See all devices from Prodent Italia S.r.l. →

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 08056284293685|805214171300A019Z 61 fields · synced 23 Oct 2026