Skip to content

Pre

by Laboratoire Precilens France EUDAMED

Ref AS Dégagement inverse - PREK - PREK TI - PREK TE - Kerato - MCKER, Enfant - Jeune - Enfant TI - Enfant TE - Jeune TI - Jeune TEModel Lentilles de contact rigides pour cornées irrégulières, Lentille de contact rigide pour controle myopie EMDN Q02100499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3666486RirregcorneeTL Basic UDI-DIDate27 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Pre
Pre Amyopic
Model / Reference
Lentilles de contact rigides pour cornées irrégulières, AS Dégagement inverse - PREK - PREK TI - PREK TE - Kerato - MCKER, Lentille de contact rigide pour controle myopie, Enfant - Jeune - Enfant TI - Enfant TE - Jeune TI - Jeune TE
Primary DI / UDI-DI
03666486000360, 03666486000506
Basic UDI-DI
3666486RirregcorneeTL, 3666486RcontrolmyopiaRL
EMDN Code
Q02100499 Contact lenses - other
Device Class
Class IIa
Special Device Type
Made to order Rigid Gas Permeable (RGP) contact lenses
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000913

Other devices from Laboratoire Precilens

See all devices from Laboratoire Precilens →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED f9e106a9-b246-49a4-b4fe-83a7a6c3b59e 61 fields · synced 22 Oct 2026
  • EUDAMED 03666486000506|3666486RCONTROLMYOPIARL 61 fields · synced 18 May 2026