Skip to content

Vivinex™ Toric multiSert™

by HOYA Medical Singapore Pte. Ltd. 328 variants

Ref XY1AT8-SP029Model Vivinex™ Toric multiSert™

Active European Union

CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04547480517032 Basic UDI-DI 04547480517032UDI-DIDate8 Oct 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
Vivinex™ Toric multiSert™, XY1AT8-SP029
Primary DI / UDI-DI
04547480517032
Basic UDI-DI
B-04547480517032
EMDN Code
P030102090301 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
SG-MF-000012053
Authorised representative
HOYA Surgical Optics GmbH DE-AR-000008535

Other devices from Hoya Medical Singapore Pte Ltd

See all devices from Hoya Medical Singapore Pte Ltd →

Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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