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Asqelio™ PairedFocus Toric Preloaded IOL Delivery System

by AST VisionCare Inc. United States EUDAMED

Ref X2PFTPIO130Y-V3

EMDN P030102100301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00197923715651 Basic UDI-DIDate4 Aug 2026RegisteredStatusActive

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 24 Oct 2026

Device Name
Asqelio™ PairedFocus Toric Preloaded IOL Delivery System
Model / Reference
X2PFTPIO130Y-V3
Primary DI / UDI-DI
00197923715651
Basic UDI-DI
B-00197923715651
EMDN Code
P030102100301 IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

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

Other devices from AST VisionCare Inc.

See all devices from AST VisionCare Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 00197923715651|B-00197923715651 61 fields · synced 24 Oct 2026