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Soczewka organiczna jednoogniskowa

by IQ VISION spółka z ograniczona odpowiedzialnością 3 variants

Ref SV OPTIMAL SF 1,67Model SV Optimal SF 1,5

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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 Number59054381008U Basic UDI-DI 05905438001351UDI-DIDate13 Jan 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Soczewka organiczna jednoogniskowa
Model / Reference
SV Optimal SF 1, 5, 67
Primary DI / UDI-DI
05905438001351
Basic UDI-DI
59054381008U
EMDN Code
Q0210010101 Monofocal organic ophthalmic lenses
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000031074

Other devices from IQ VISION spółka z ograniczona odpowiedzialnością

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • 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