Skip to content

Fresa-Preparatore di spalla

by Saeg srl EUDAMED

Active European Union

Ref FPS-350

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805361029FREPSPCD Basic UDI-DIDate1 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030024-01 Issued

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    8 May 2023
    Expires
    7 May 2028

Specification

EUDAMED

Device Name
FREPSP Fresa-Preparatore di spalla
Model / Reference
FPS-350
Primary DI / UDI-DI
08053610298550
Basic UDI-DI
805361029FREPSPCD
EMDN Code
L149009 ENT surgery burs, reusable
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000022747

Other devices from Saeg SRL

See all devices from Saeg SRL →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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