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Algeness Df

by Ghimas S.p.A. Italy EUDAMED

Ref PFMD0141

EMDN P900402,Y062703

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803357637ALGENESS35ZC Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • EPT 0477.MDR.23/5038.1 Reissued

    Technical documentation EU MDR

    Notified body
    Notified body 0477
    Issued
    18 Jul 2024
    Expires
    16 Jan 2028
  • EPT 0477.MDR.23/5039.1 Reissued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    18 Jul 2024
    Expires
    16 Jan 2028

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Algeness Df
Model / Reference
PFMD0141
Primary DI / UDI-DI
18033576370047
Basic UDI-DI
803357637ALGENESS35ZC
EMDN Code
P900402,Y062703
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000017070

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 f188c4f7-428c-432e-a4ea-55fc15870ffe 61 fields · synced 23 Oct 2026