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Gerdoff

by Sofar Swiss SA Switzerland EUDAMED

Ref GF-04LModel MELT IN MOUTH TABLETS

EMDN G99

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number764015897GERDOFFSE Basic UDI-DIDate15 Oct 2025RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDR Withdrawn

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • CSQ0028250925 Supplemented

    Quality management system EU MDR

    Issued
    26 May 2025
    Expires
    23 Apr 2030
    Reason
    Add device or group
  • CVD0043250725 Supplemented

    Technical documentation EU MDR

    Issued
    14 May 2025
    Expires
    23 Apr 2030
    Reason
    Change approved

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
MELT IN MOUTH TABLETS, GF-04L
Primary DI / UDI-DI
07640158970492
Basic UDI-DI
764015897GERDOFFSE
Direct Marketing DI
07640158970492
EMDN Code
G99 Gastrointestinal devices - other
Device Class
Class III

Manufacturer details

EUDAMED SRN
CH-MF-000047475
Authorised representative
ALFASIGMA S.P.A. IT-AR-000047395

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See all devices from Sofar Swiss SA →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 07640158970492|764015897GERDOFFSE 61 fields · synced 24 Oct 2026