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11K30301

by Bone System SRL

Ref 11K30301Model Two-stage dental implant

Active European Union

CE MDR

Valid until

1 Dec 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0425-MDR-030161-00 Date2 Dec 2025IssuedStatusActive expires 1 Dec 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030161-00 Active

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    2 Dec 2025
    Expires
    1 Dec 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Two-stage dental implant, 11K30301
Primary DI / UDI-DI
08056249730798
Basic UDI-DI
805624973IMPBIFK4
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000040985

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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