Skip to content

Biotrue ONEday For Astigmatism (nesofilcon A) Contact Lenses

by Bausch & Lomb Incorporated

Ref Many

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0310119B0017Z8 Basic UDI-DI 0196527M0003GGUDI-DIDate8 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Soft Corrective Contact Lens, Daily-Disposable (nesofilcon A)
Model / Reference
Many
Primary DI / UDI-DI
0196527M0003GG
Basic UDI-DI
0310119B0017Z8
EMDN Code
Q021004010101 Contact lenses - hydrogel, daily single-use
Device Class
Class IIa
Special Device Type
Standard soft contact lenses
EU 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

  • 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