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Hydrophilic Acrylic Foldable IOL - Clear

by Eyekon Medical Inc.

Ref FS25B-UV +10.0

Active European Union

CE MDR

Valid until

13 Jul 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000171284 Date14 Jul 2026IssuedStatusActive expires 13 Jul 2031

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000171284 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    14 Jul 2026
    Expires
    13 Jul 2031
  • 1000289397 Active

    Technical documentation EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    14 Jul 2026
    Expires
    13 Jul 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Hydrophilic Acrylic Foldable IOL - Clear
Model / Reference
FS25B-UV +10.0
Primary DI / UDI-DI
00840570400004
Basic UDI-DI
08405704HA-IOL-CLEARZ6
Direct Marketing DI
00840570400004
EMDN Code
P030102090202 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000046490
Authorised representative
MedEnvoy Global BV NL-AR-000024028

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See all devices from Eyekon Medical, Inc. →

Properties

  • Sterile
  • Implantable

Other properties (12)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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