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fixOflex

by Eye Pcr BV EUDAMED 2 variants

Active European Union

Ref CR3

Regulatory status

as of 29 Oct 2026

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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

Specification

EUDAMED

Model / Reference
CR3
Primary DI / UDI-DI
05213014810038
Basic UDI-DI
521301481fixOflexCX
EMDN Code
P030199 Intraocular lenses (iol) - other
Device Class
Class IIb
Market of Registration
Greece

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