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Hba 5433OR

by ZIACOM ITS S.r.l.

Part of a family of 7 devices: see the family page

Ref HBA 5433ORModel O ring abutment

Hba 5433OR is a Class IIb device made by ZIACOM ITS S.r.l., registered in EUDAMED on 14 Sep 2026 (Basic UDI-DI 805957100ORINGHF) with CE/MDR certificate 0425-MDR-030118-02 valid until 21 Jan 2030, active as of 24 Oct 2026.

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

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805957100ORINGHF Basic UDI-DI 08059571002465UDI-DIDate14 Sep 2026RegisteredStatusActive

Official records

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

Timeline

3 dated events

  1. Certificate issued EUDAMED 0425-MDR-030118-02
  2. Registered EUDAMED 805957100ORINGHF
  3. Certificate expires EUDAMED 0425-MDR-030118-02

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
O ring abutment, HBA 5433OR
Primary DI / UDI-DI
08059571002465
Basic UDI-DI
805957100ORINGHF
EMDN code
P01020180 Dental implants - accessories
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000028897

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from ZIACOM ITS S.r.l.

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

Properties

  • Sterilise before use
  • Implantable
  • Sutures
Other properties (12, all answered No)