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Boston XO

by Bausch & Lomb Incorporated United States EUDAMED

Ref Spec0302

EMDN Q02100402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0310119B0030YY Basic UDI-DIDate21 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
Boston XO (hexafocon A) Rigid Gas Permeable Contact Lenses
Model / Reference
Spec0302
Primary DI / UDI-DI
0196527M0068HC
Basic UDI-DI
0310119B0030YY
EMDN Code
Q02100402 Contact lenses - non hydrogel
Device Class
Class IIa
Special Device Type
Standard Rigid Gas Permeable (RGP) Contact Lenses
Market of Registration
Ireland

Manufacturer details

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

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 (1)

  • EUDAMED 0196527M0068HC|0310119B0030YY 61 fields · synced 24 Oct 2026