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SofLens Multi-Focal

by Bausch & Lomb Incorporated United States EUDAMED

Ref Many

EMDN Q0210040102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0310119B0013YY Basic UDI-DIDate11 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Soft Contact Lenses, Daily-Wear and Extended Wear (polymacon)
Model / Reference
Many
Primary DI / UDI-DI
0196527M0074H7
Basic UDI-DI
0310119B0013YY
EMDN Code
Q0210040102 Contact lenses - hydrogel, reusable
Device Class
Class IIa
Special Device Type
Standard soft contact lenses
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000001029
Authorised representative
Bausch & Lomb Incorporated IE-AR-000000094

Other devices from Bausch & Lomb Incorporated

See all devices from Bausch & Lomb Incorporated →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • CMR Substance
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 0196527M0074H7|0310119B0013YY 61 fields · synced 24 Oct 2026