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Dental Implants -Biphasic

by ZIACOM ITS S.r.l. 131 variants

Ref CL 1137FX2Model DENTAL IMPLANTS -BIPHASIC

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805957100IMPIANTI63 Basic UDI-DIDate19 May 2026RegisteredStatusActive

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Dental Implants -Biphasic
Model / Reference
DENTAL IMPLANTS -BIPHASIC, CL 1137FX2
Primary DI / UDI-DI
08059571000775
Basic UDI-DI
805957100IMPIANTI63
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000028897

Other devices from ZIACOM ITS S.r.l.

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    Class IIb

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Properties

  • Sterile
  • Implantable
  • Sutures

Other properties (11)

  • 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