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Sterile Intragastric Balloon

by Medicone Projetos e Solucoes para a Industria e a Saude Ltda. Brazil EUDAMED

Ref 94601Model STERILE INTRAGASTRIC BALLOON EMDN G030601

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07898258291089 Basic UDI-DIDate2 May 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
STERILE INTRAGASTRIC BALLOON, 94601
Primary DI / UDI-DI
07898258291089
Basic UDI-DI
B-07898258291089
EMDN Code
G030601 Intragastric balloon systems
Device Class
Class IIb
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
BR-MF-000026420
Authorised representative
Rápido e Contínuo Unipessoal LDA PT-AR-000039288

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • 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 c266e378-cf13-4306-ae9a-df7404d93aa3 61 fields · synced 22 Oct 2026