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Degasin® Simethicone 280 mg

by WALMARK, a.s. 2 variants

Active European Union

CE MDR

Valid until

30 Jan 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2026-MDR/QS-011/B Date27 Aug 2026IssuedStatusActive expires 30 Jan 2031

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2026-MDR/QS-011/B Active Amended

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    27 Aug 2026
    Expires
    30 Jan 2031
    Reason
    Other
  • 2026-MDR/TD-011/B Active Amended

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    27 Aug 2026
    Expires
    30 Jan 2031
    Reason
    Other

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Degasin 280 mg
Primary DI / UDI-DI
08596024030038
Basic UDI-DI
8596024DEGASIN280MG2K
EMDN Code
G99 Gastrointestinal devices - other
Device Class
Class III
EU market of registration
Slovenia

Manufacturer details

EUDAMED SRN
CZ-MF-000007035

Other devices from WALMARK, a.s.

See all devices from WALMARK, a.s. →

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