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RegenOss Ortho

by Fin-ceramica faenza spa 4 variants

Ref 01600815Model RegenOss

Active European Union

CE MDR CE MDD

Valid until

12 Mar 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier ISTITUTO SUPERIORE DI SANITA'

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCSQ0008230326 Date31 Mar 2026IssuedStatusActive expires 12 Mar 2028
European UnionCE/MDD NumberB-18054188160529 Basic UDI-DIDate28 Jul 2022RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Trade Name
RegenOss Ortho
RegenOss
Model / Reference
01600815, RegenOss
Primary DI / UDI-DI
18054188160529
Basic UDI-DI
B-18054188160529, 805418816RegenOssKS
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000023496

Other devices from Fin-ceramica faenza spa

See all devices from Fin-ceramica faenza spa →

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