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Fresa PROSHAPE Ø 3 per osso COMPATTO

by Prodent Italia S.r.l.

Ref 2403250

Active European Union

CE MDR

Valid until

26 Sep 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier ICIM S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805214171300A019Z Basic UDI-DI 08056284293562UDI-DIDate18 May 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 0425-MDR-030042-04 Active

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    20 Jun 2025
    Expires
    26 Sep 2028
  • 0425-MDR-030042-04 Active Removed from EUDAMED

    Quality management system EU MDR

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Strumenti di Taglio in Acciaio / Steel Cutting Tools
Model / Reference
2403250
Primary DI / UDI-DI
08056284293562
Basic UDI-DI
805214171300A019Z
EMDN Code
Q010399 Surgical dental devices - other
Device Class
Class IIa
EU 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

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