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Macrogol sachets

by S.I.I.T. srl Italy EUDAMED

Ref GC04A1 GC04A2 GC04B1 GC04B2 GC04C1 GC04C2 GC04M1 GC04M2 GC04G GC04N1 GC04N2 GC04N3Model GC04S EMDN G0401

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805759247GC04SB5 Basic UDI-DIDate11 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
GC04S, GC04A1 GC04A2 GC04B1 GC04B2 GC04C1 GC04C2 GC04M1 GC04M2 GC04G GC04N1 GC04N2 GC04N3
Primary DI / UDI-DI
08057592470546
Basic UDI-DI
805759247GC04SB5
EMDN Code
G0401 Orally administered devices for the therapy of gastro-intestinal disorders
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000022188

Other devices from S.I.I.T. srl

See all devices from S.I.I.T. srl →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED f1bd7721-0e3f-4831-896f-31cac54e6bd0 61 fields · synced 25 Oct 2026