Skip to content

STELLA Endogastric Balloon Kit

by Mikromic Medical Sl Spain EUDAMED

Ref 9092K981

EMDN G030601

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number84370251359092K981ME Basic UDI-DIDate26 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
STELLA Endogastric Balloon Kit
Model / Reference
9092K981
Primary DI / UDI-DI
08437025135011
Basic UDI-DI
84370251359092K981ME
EMDN Code
G030601 Intragastric balloon systems
Device Class
Class IIb
Medical Purpose
STELLA Endogastric Balloon Kit: - Stella Endogastric Balloon System (9092981) - Transferset with double check valve 160 cm, tubing 2,4x4,1 mm, spike, rollerclamp (DDS2048) It is intended to be used in a clinical setting by healthcare professionals trained in endoscopy, to treat adult patients with obesity or other health-risk factors related to being overweight, and who have failed to achieve and maintain weight loss. When deployed and inflated in the stomach, the balloon reduces stomach capacity, promoting a feeling of satiety and reducing the desire for food thereby enabling weight loss maintenance

Manufacturer details

EUDAMED SRN
ES-PR-000046348

Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 8aca0cbd-490b-46b0-8619-2c6587b8e715 61 fields · synced 22 Oct 2026