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Bieffe Hcp

by Biofarma S.r.l. Italy EUDAMED

Ref NA

EMDN G0401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8053307840002XF Basic UDI-DIDate9 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • EPT 0477.MDR.26/6275 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0477
    Issued
    7 Sep 2026
    Expires
    6 Sep 2031
  • EPT 0477.MDR.26/6276 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    7 Sep 2026
    Expires
    6 Sep 2031

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
NA
Primary DI / UDI-DI
08053307840123
Basic UDI-DI
8053307840002XF
EMDN Code
G0401 Orally administered devices for the therapy of gastro-intestinal disorders
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000024710

Other devices from Biofarma S.r.l.

See all devices from Biofarma S.r.l. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
Other properties (12)
  • Sterile: No
  • Implantable: No
  • 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

Sources (1)

  • EUDAMED 08053307840123|8053307840002XF 61 fields · synced 25 Oct 2026