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Surgical accessories

by ZIACOM ITS S.r.l. 130 variants

Ref HTP 5530 KModel Surgical accessories

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 Number805957100ACCESSORICL.1MV Basic UDI-DI 08059571003417UDI-DIDate11 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  • Withdrawn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 accessories
Model / Reference
Surgical accessories, HTP 5530 K
Primary DI / UDI-DI
08059571003417
Basic UDI-DI
805957100ACCESSORICL.1MV
EMDN Code
Q010280 Prosthetic dentistry devices - accessories
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000028897

Other devices from ZIACOM ITS S.r.l.

  • Dental Implants -Biphasic

    Class IIb

  • Surgical instruments

    Class IIa

  • Surgical accessories

    Class I

  • Cover Screw

    Class IIb

  • Kpk 2663

    Class IIb

  • Kpk 2760

    Class IIb

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

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