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Asqelio™ Pluris Toric Preloaded IOL Delivery System

by AST VisionCare Inc. United States EUDAMED

Ref C1UTPIO130Y-V3

EMDN P030102090301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00197923641493 Basic UDI-DIDate28 Jul 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™ Pluris Toric Preloaded IOL Delivery System
Model / Reference
C1UTPIO130Y-V3
Primary DI / UDI-DI
00197923641493, 00197923642537, 00197923646771, 00197923640236, 00197923644722, 00197923645385, 00197923645323, 00197923647372, 00197923642704, 00197923643299, 00197923640434, 00197923644456
Basic UDI-DI
B-00197923641493, B-00197923642537, B-00197923646771, B-00197923640236, B-00197923644722, B-00197923645385, B-00197923645323, B-00197923647372, B-00197923642704, B-00197923643299, B-00197923640434, B-00197923644456
EMDN Code
P030102090301 IOLs, APHAKIC, MONOFOCAL, 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 (12)

  • EUDAMED 590fad07-202e-4a6c-a80e-2df53640155e 61 fields · synced 24 Oct 2026
  • EUDAMED 00197923642537|B-00197923642537 61 fields · synced 17 May 2026
  • EUDAMED 00197923646771|B-00197923646771 61 fields · synced 17 May 2026
  • EUDAMED 00197923640236|B-00197923640236 61 fields · synced 17 May 2026
  • EUDAMED 00197923644722|B-00197923644722 61 fields · synced 17 May 2026
  • EUDAMED 00197923645385|B-00197923645385 61 fields · synced 17 May 2026
  • EUDAMED 00197923645323|B-00197923645323 61 fields · synced 17 May 2026
  • EUDAMED 00197923647372|B-00197923647372 61 fields · synced 18 May 2026
  • EUDAMED 00197923642704|B-00197923642704 61 fields · synced 19 May 2026
  • EUDAMED 00197923643299|B-00197923643299 61 fields · synced 19 May 2026
  • EUDAMED 00197923640434|B-00197923640434 61 fields · synced 19 May 2026
  • EUDAMED 00197923644456|B-00197923644456 61 fields · synced 19 May 2026