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Celora Lumo

by Italfarmacia srl Italy EUDAMED

Ref ITF003/a3Model Linea SKIN-OX EMDN P900402

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCSQ0006237126 Date30 Apr 2026IssuedStatusWithdrawn Not intended for the EU market expires 2 Mar 2028

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • CSQ0006237126 Supplemented

    Quality management system EU MDR

    Issued
    30 Apr 2026
    Expires
    2 Mar 2028
    Reason
    Add device or group
  • CVD0013231426 Supplemented

    Technical documentation EU MDR

    Issued
    30 Apr 2026
    Expires
    2 Mar 2028
    Reason
    Add device or group

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Skin-Ox
Model / Reference
Linea SKIN-OX, ITF003/a3
Primary DI / UDI-DI
08055715336434
Basic UDI-DI
805571533ITF0038Z
Direct Marketing DI
08055715336434
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III

Manufacturer details

EUDAMED SRN
IT-MF-000013116

Other devices from Italfarmacia srl

See all devices from Italfarmacia srl →

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 2ad20c86-426d-4411-a5df-a5e044ef1cdd 61 fields · synced 22 Oct 2026