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Aurovue Dfine Preloaded IOL

by Aurolab

Ref NilModel HP760AD3

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-803878HPD0014SX8 Basic UDI-DI D-803878HPD0014SX8UDI-DIDate15 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  • Withdrawn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

Device Name
Preloaded Hydrophobic Foldable Intraocular Lenses
Model / Reference
HP760AD3, Nil
Primary DI / UDI-DI
D-803878HPD0014SX8
Basic UDI-DI
B-803878HPD0014SX8
EMDN Code
P030102100101 IOLs, APHAKIC, MULTIFOCAL, SPHERICAL, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000007255
Authorised representative
mdi Europa GmbH DE-AR-000006218

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Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No