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Enova

by VSY Biotechnology GmbH 804 variants

Ref ENOVA ADC

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-04064544396797 Basic UDI-DI Date15 Sep 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  • Withdrawn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
Enova Adc
Model / Reference
ENOVA ADC
Primary DI / UDI-DI
04064544396797, 04064544396674, 04064544397060, 04064544397169, 04064544397176, 04064544396018, 04064544398227, 04064544396025, 04064544397978, 04064544396728, 04064544397961, 04064544396032, 04064544396711, 04064544397121, 04064544398036, 04064544398265, 04064544397114, 04064544398296, 04064544397930, 04064544398197, 04064544396681, 04064544397138, 04064544398050, 04064544398272, 04064544396759, 04064544397916, 04064544398241, 04064544397091, 04064544397893, 04064544396001, 04064544398258, 04064544398005, 04064544397053, 04064544397909, 04064544397947, 04064544396773, 04064544395981, 04064544397077, 04064544398210, 04064544397923, 04064544395967, 04064544397107, 04064544397992, 04064544398302, 04064544396742, 04064544398203, 04064544398012, 04064544397985
Basic UDI-DI
B-04064544396797, B-04064544396674, B-04064544397060, B-04064544397169, B-04064544397176, B-04064544396018, B-04064544398227, B-04064544396025, B-04064544397978, B-04064544396728, B-04064544397961, B-04064544396032, B-04064544396711, B-04064544397121, B-04064544398036, B-04064544398265, B-04064544397114, B-04064544398296, B-04064544397930, B-04064544398197, B-04064544396681, B-04064544397138, B-04064544398050, B-04064544398272, B-04064544396759, B-04064544397916, B-04064544398241, B-04064544397091, B-04064544397893, B-04064544396001, B-04064544398258, B-04064544398005, B-04064544397053, B-04064544397909, B-04064544397947, B-04064544396773, B-04064544395981, B-04064544397077, B-04064544398210, B-04064544397923, B-04064544395967, B-04064544397107, B-04064544397992, B-04064544398302, B-04064544396742, B-04064544398203, B-04064544398012, B-04064544397985
EMDN Code
P030102100201 IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000025210

Other devices from VSY Biotechnology GmbH

See all devices from VSY Biotechnology GmbH →

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