Skip to content

ALINAN COLIC AND BLOATING (emulsion)

by Fiterman Pharma SRL Romania EUDAMED

Ref BXMEDEM EMDN G0401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-BXMEDEM79 Basic UDI-DIDate14 Mar 2022RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Device Name
BALONIX MED (emulsion)
Model / Reference
BXMEDEM
Primary DI / UDI-DI
D-BXMEDEM79
Basic UDI-DI
B-BXMEDEM79
EMDN Code
G0401 Orally administered devices for the therapy of gastro-intestinal disorders
Device Class
Class IIa
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
RO-MF-000001410

Other devices from Fiterman Pharma SRL

See all devices from Fiterman Pharma 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 (1)

  • EUDAMED 9b842b21-9a52-496d-8c3f-e9bd7a1106d1 61 fields · synced 24 Oct 2026