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Heliosphere Extraction Kit

by Helioscopie S.A.S. EUDAMED

Active European Union

Ref Extraction KitModel Heliosphere Extraction Kit

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number376033165EXTRACTIONKITQE Basic UDI-DIDate18 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Extraction Kit
Model / Reference
Heliosphere Extraction Kit, Extraction Kit
Primary DI / UDI-DI
03760331650134
Basic UDI-DI
376033165EXTRACTIONKITQE
EMDN Code
G030602 Devices for removal of intragastric balloons
Device Class
Class I
Medical Purpose
Removal of Heliosphere Intragastric Balloon

Manufacturer details

EUDAMED SRN
FR-PR-000057567

Other devices from Helioscopie

Properties

  • Sterile