Skip to content

SmartBone ORTHO

by Industrie Biomediche Insubri SA 113 variants

Ref SBO18164C

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD NumberB-07640178687851 Basic UDI-DI 07640178687851UDI-DIDate14 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
SmartBone ORTHO Rounded block 18x16x4 mm
Model / Reference
SBO18164C
Primary DI / UDI-DI
07640178687851
Basic UDI-DI
B-07640178687851
EMDN Code
P900401 Bone and tendon replacement devices
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CH-MF-000049165
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Other devices from Industrie Biomediche Insubri SA

See all devices from Industrie Biomediche Insubri SA →

Properties

  • Sterile
  • Implantable
  • Animal Tissues

Other properties (10)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No