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Monobloc(r) Silicone SoftOne(r)

by Laboratoires Arion EUDAMED

Active European Union

Ref GS-A2XH445-MTModel GS-A2XH-445-MT

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03760136510121 Basic UDI-DIDate26 May 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Monobloc(r) Silicone SoftOne(r) breast implant, anatomical, microtextured, 445 cc
Model / Reference
GS-A2XH-445-MT, GS-A2XH445-MT
Primary DI / UDI-DI
03760136510121
Basic UDI-DI
B-03760136510121
EMDN Code
P0601020202 Breast implants, anatomical, made of silicone, with textured surface
Device Class
Class III
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000025697

Other devices from Laboratoires Arion

See all devices from Laboratoires Arion →

Properties

  • 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