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Asqelio™ Pluris Preloaded IOL Delivery System

by AST VisionCare Inc. EUDAMED

Active European Union

Ref UPIO130Y

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00840149889209 Basic UDI-DIDate28 Jul 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  • Withdrawn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
Asqelio™ Pluris Preloaded IOL Delivery System
Model / Reference
UPIO130Y
Primary DI / UDI-DI
00840149889209, 00840149888851, 00840149888868, 00840149889087, 00840149888677, 00840149889155, 00840149889117, 00840149888837, 00840149888844, 00840149888974, 00840149888882, 00840149888639, 00840149889063, 00840149888936
Basic UDI-DI
B-00840149889209, B-00840149888851, B-00840149888868, B-00840149889087, B-00840149888677, B-00840149889155, B-00840149889117, B-00840149888837, B-00840149888844, B-00840149888974, B-00840149888882, B-00840149888639, B-00840149889063, B-00840149888936
EMDN Code
P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000021852
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Sterile
  • Implantable

Other properties (11)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No