Skip to content

Quantum I

by Bausch & Lomb Incorporated

Ref Spec0304

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0310119B0034Z8 Basic UDI-DI 0196527M0072H3UDI-DIDate21 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  • Withdrawn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
Quantum I (siflufocon A) Rigid Gas Permeable Contact Lenses
Model / Reference
Spec0304
Primary DI / UDI-DI
0196527M0072H3
Basic UDI-DI
0310119B0034Z8
EMDN Code
Q02100402 Contact lenses - non hydrogel
Device Class
Class IIa
Special Device Type
Standard Rigid Gas Permeable (RGP) Contact Lenses
EU market of registration
Ireland

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

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