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Pessaire Gyn&Dish a/V Bouton T2 - 60 Mm

by Medgyn International, Inc United States EUDAMED

Ref 47856

EMDN U089005

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-47856 Basic UDI-DIDate25 Mar 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Pessaire Gyn&Dish a/V Bouton T2 - 60 Mm
Model / Reference
47856
Primary DI / UDI-DI
47856
Basic UDI-DI
B-47856
EMDN Code
U089005 Pessarians
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000031450
Authorised representative
Advena Limited MT-AR-000000234

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 1284f49c-6bf2-4bba-bd8c-47c4751d88c5 61 fields · synced 22 Oct 2026