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Asqelio™ PairedFocus Preloaded IOL Delivery System

by AST VisionCare Inc. 24 variants

Ref X2PFPIO130Y-V3

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00197923704600 Basic UDI-DI Date4 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Asqelio™ PairedFocus Preloaded IOL Delivery System
Model / Reference
X2PFPIO130Y-V3
Primary DI / UDI-DI
00197923704600, 00197923704471, 00197923704389, 00197923704402, 00197923704686, 00197923704723, 00197923704778, 00197923704358, 00197923704365, 00197923704457, 00197923704662, 00197923704440, 00197923704525, 00197923704808, 00197923704679, 00197923704532, 00197923704570, 00197923704396, 00197923704556, 00197923704846, 00197923704334, 00197923704877, 00197923704419, 00197923704761, 00197923704754, 00197923704624, 00197923704891, 00197923704563, 00197923704631, 00197923704617, 00197923704709, 00197923704501, 00197923704433, 00197923704341, 00197923704549, 00197923704716, 00197923704860, 00197923704884, 00197923704594, 00197923704655, 00197923704815, 00197923704587, 00197923704907, 00197923704495, 00197923704518, 00197923704914, 00197923704693, 00197923704488, 00197923704822, 00197923704792
Basic UDI-DI
B-00197923704600, B-00197923704471, B-00197923704389, B-00197923704402, B-00197923704686, B-00197923704723, B-00197923704778, B-00197923704358, B-00197923704365, B-00197923704457, B-00197923704662, B-00197923704440, B-00197923704525, B-00197923704808, B-00197923704679, B-00197923704532, B-00197923704570, B-00197923704396, B-00197923704556, B-00197923704846, B-00197923704334, B-00197923704877, B-00197923704419, B-00197923704761, B-00197923704754, B-00197923704624, B-00197923704891, B-00197923704563, B-00197923704631, B-00197923704617, B-00197923704709, B-00197923704501, B-00197923704433, B-00197923704341, B-00197923704549, B-00197923704716, B-00197923704860, B-00197923704884, B-00197923704594, B-00197923704655, B-00197923704815, B-00197923704587, B-00197923704907, B-00197923704495, B-00197923704518, B-00197923704914, B-00197923704693, B-00197923704488, B-00197923704822, B-00197923704792
EMDN Code
P030102100201 IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
EU 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

  • 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