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OMEGA LAA Occluder 16mm

by Eclipse Medical Co. Ltd Thailand EUDAMED

Ref OLAA16 EMDN P070404

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08857127156033 Basic UDI-DIDate21 Mar 2022RegisteredStatusActive

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  • Withdrawn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
OLAA16
Primary DI / UDI-DI
08857127156033
Basic UDI-DI
B-08857127156033
EMDN Code
P070404 Left atrial appendage occluders
Device Class
Class III
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
TH-MF-000021672
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Eclipse Medical Co. Ltd

See all devices from Eclipse Medical Co. Ltd →

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 2b277847-9257-4f8e-b201-91aec6d448fb 61 fields · synced 22 Oct 2026