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Allurion Stylet

by Allurion Technologies Inc. United States EUDAMED

Ref 12D-CEModel FD012-10

EMDN G030601

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-FD012-10QD Basic UDI-DIDate17 Jun 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

Model / Reference
FD012-10, 12D-CE
Primary DI / UDI-DI
D-FD012-10QD
Basic UDI-DI
B-FD012-10QD
EMDN Code
G030601 Intragastric balloon systems
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000001377
Authorised representative
ICON (LR) Limited IE-AR-000006507

Other devices from Allurion Technologies Inc.

Properties & raw data

Show properties, registry sources and raw records
  • Implantable
Other properties (10)
  • Sterile: 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 7e95e11f-f107-4979-bc98-f7e32bfff336 61 fields · synced 22 Oct 2026