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Gelsectan

by Devintec Sagl Switzerland EUDAMED

Ref C05B02E060 EMDN G0401

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberIT326645 Date18 Mar 2025IssuedStatusActive expires 7 Sep 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IT326645 Supplemented

    Technical documentation EU MDR

    Notified body
    BUREAU VERITAS ITALIA S.P.A. 1370
    Issued
    18 Mar 2025
    Expires
    7 Sep 2028
    Reason
    Add device or group

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
C05B02E060
Primary DI / UDI-DI
07649993626045
Basic UDI-DI
7649993626FT42301VC
Direct Marketing DI
07649993626045
EMDN Code
G0401 Orally administered devices for the therapy of gastro-intestinal disorders
Device Class
Class III
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CH-MF-000020271
Authorised representative
DEVINTEC HEALTH S.L. ES-AR-000020256

Other devices from Devintec Sagl

See all devices from Devintec Sagl →

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 75b2d413-e1da-4021-a377-b7ba5718842d 61 fields · synced 25 Oct 2026