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sab simplex

by HÄLSA Pharma GmbH EUDAMED

Active European Union

Ref CATA-MD301-00000Model Simeticone Capsules

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42517781MD301CF Basic UDI-DIDate12 Jun 2026RegisteredStatusActive

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  • Withdrawn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)
  • 20416GB450260423 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 0482
    Issued
    23 Apr 2026
    Expires
    26 Feb 2029
    Reason
    Change approved

Specification

EUDAMED

Model / Reference
Simeticone Capsules, CATA-MD301-00000
Primary DI / UDI-DI
04251778103776, 04251778103769
Basic UDI-DI
42517781MD301CF
EMDN Code
G0401 Orally administered devices for the therapy of gastro-intestinal disorders
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000007407

Other devices from HÄLSA Pharma GmbH

See all devices from HÄLSA Pharma GmbH →

Properties

  • Animal Tissues

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No