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13K10101

by Bone System SRL EUDAMED

Active European Union

Ref 13K10101Model Two-stage dental implant

Regulatory status

as of 29 Oct 2026

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

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  • Withdrawn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-030161-00 Active

    Quality management system EU MDR

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

Specification

EUDAMED

Model / Reference
Two-stage dental implant, 13K10101
Primary DI / UDI-DI
08056249730941
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