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Lenodiar Pediatric

by Aboca S.P.A. Società Agricola Italy EUDAMED

Ref 08032472011903

EMDN G0401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8032472LENOby232 Basic UDI-DIDate11 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • EPT 0477.MDR.25/5831 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0477
    Issued
    21 May 2025
    Expires
    20 May 2030
  • EPT 0477.MDR.25/5832 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    21 May 2025
    Expires
    2 Nov 2028

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Antidiarroico pediatric
Model / Reference
08032472011903
Primary DI / UDI-DI
08032472011903
Basic UDI-DI
8032472LENOby232
EMDN Code
G0401 Orally administered devices for the therapy of gastro-intestinal disorders
Device Class
Class III
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
IT-MF-000029499

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 f87b84c2-90ed-4ac6-a912-6f8f428a7fbf 61 fields · synced 24 Oct 2026