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Bex-S01

by ZIACOM ITS S.r.l. EUDAMED

Active European Union

Ref BEX-S01Model Surgical instruments

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805957100STRMANR3 Basic UDI-DIDate10 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

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

    Quality management system EU MDR

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

Specification

EUDAMED

Model / Reference
Surgical instruments, BEX-S01
Primary DI / UDI-DI
08059571000256
Basic UDI-DI
805957100STRMANR3
EMDN Code
L150101 Odontostomatology osteotomes, reusable
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000028897

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Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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