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ColoCalm Duo

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

Ref GC03 EMDN G0401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-0600806272 Basic UDI-DIDate19 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
ColoCalm Duo
ColoCalm Duo (20 tablets)
Device Name
ColoCalm Duo (40 tablets)
Model / Reference
GC03
Primary DI / UDI-DI
D-0600806272, D-060080706Z
Basic UDI-DI
B-0600806272, B-060080706Z
EMDN Code
G0401 Orally administered devices for the therapy of gastro-intestinal disorders
Device Class
Class IIa
Market of Registration
Germany

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 (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED 8360880d-e3ef-4ef0-a3b4-cfdfaab4b26c 61 fields · synced 22 Oct 2026
  • EUDAMED D-060080706Z|B-060080706Z 61 fields · synced 17 May 2026