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b.Bone

by GreenBone Ortho Spa Italy EUDAMED

Ref HC201030PS

EMDN P900401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number044-00-01-MDR Date20 Apr 2026IssuedStatusActive expires 5 Mar 2029

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 044-00-01-MDR Supplemented

    Technical documentation EU MDR

    Notified body
    ITALCERT SRL 0426
    Issued
    20 Apr 2026
    Expires
    5 Mar 2029
    Reason
    Change approved

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
HC201030PS
Primary DI / UDI-DI
08053848340595
Basic UDI-DI
805384834IP01R3D01M01DD
EMDN Code
P900401 Bone and tendon replacement devices
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000033034

Other devices from GreenBone Ortho Spa

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    Class III

  • b.Bone

    Class III

  • b.Bone

    Class III

  • b.Bone

    Class III

See all devices from GreenBone Ortho Spa →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
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

Sources (1)

  • EUDAMED 8675faa9-90aa-4cd1-b7b0-9ee5f77edda3 61 fields · synced 22 Oct 2026