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fixOflex

by Eye Pcr BV 2 variants

Ref F1

Active European Union

CE MDR

Valid until

6 Jan 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier HTCert (Health Technology Certification Ltd)

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/MDR NumberC07 NL037443 2601 Date24 Jul 2026IssuedStatusActive expires 6 Jan 2031

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • C07 NL037443 2601 Active

    Technical documentation EU MDR

    Notified body
    HTCert (Health Technology Certification Ltd) 2803
    Issued
    24 Jul 2026
    Expires
    6 Jan 2031
  • C08 NL037443 2601 Active

    Quality management system EU MDR

    Notified body
    HTCert (Health Technology Certification Ltd) 2803
    Issued
    24 Jul 2026
    Expires
    6 Jan 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
F1
Primary DI / UDI-DI
05213014810045
Basic UDI-DI
521301481fixOflexCX
EMDN Code
P030199 Intraocular lenses (iol) - other
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
NL-MF-000037443

Other devices from Eye Pcr BV

  • fixOflex

    Class IIb

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