Skip to content

Spectacle Lenses

by ESSILORLUXOTTICA ASIA PACIFIC PTE LTD. TGT Taiwan Branch (SINGAPORE) 5 variants

Model Index 1.50

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471989278SL001LE Basic UDI-DI 04719892780056UDI-DIDate12 Oct 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Spectacle Lenses
Model / Reference
Index 1.50
Primary DI / UDI-DI
04719892780056
Basic UDI-DI
471989278SL001LE
EMDN Code
Q0210010101, Q0210010102, Q0210010103, Q0210010199, Q0210010201, Q0210010202, Q0210010203, Q0210010299
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
TW-MF-000028859
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from ESSILORLUXOTTICA ASIA PACIFIC PTE LTD. TGT Taiwan Branch (SINGAPORE)

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