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PROKTIS-M PLUS Rektální mast

by FARMA-DERMA S.r.l. EUDAMED

Active European Union

Ref 2019

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberEPT 0477.MDR.23/5102.1 Date21 Nov 2025IssuedStatusActive expires 19 Dec 2027

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  • Withdrawn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)
  • EPT 0477.MDR.23/5102.1 Reissued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    21 Nov 2025
    Expires
    19 Dec 2027

Specification

EUDAMED

Device Name
Proktis-M PLUS unguento rettale
Model / Reference
2019
Primary DI / UDI-DI
08032595871774
Basic UDI-DI
803259587TF06EM
EMDN Code
G05 Topical anorectal administered gastro-intestinal system devices
Device Class
Class IIb
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
IT-MF-000020737

Other devices from FARMA-DERMA S.r.l.

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • 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