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Surgical instruments

by ZIACOM ITS S.r.l. 139 variants

Ref DR 8115Model Surgical instruments

Active European Union

CE MDR

Valid until

21 Jan 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier ICIM S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805957100STRUMENTARIO9V Basic UDI-DIDate26 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030118-02 Active

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    17 Apr 2026
    Expires
    21 Jan 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Surgical instruments
Model / Reference
Surgical instruments, DR 8115
Primary DI / UDI-DI
08059571001314
Basic UDI-DI
805957100STRUMENTARIO9V
EMDN Code
Z12110102 Dental drills
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000028897

Other devices from ZIACOM ITS S.r.l.

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See all devices from ZIACOM ITS S.r.l. →

Properties

  • Reusable
  • Contains Latex

Other properties (11)

  • Sterile: No
  • Implantable: 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