Skip to content

Helenvision Balance

by NTC Srl Italy EUDAMED

Ref DEX042Model Ophtalmic gel with dexpanthenol EMDN Q02030399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803413527THENOPHTHLMCGLST Basic UDI-DIDate12 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
Ophtalmic gel with dexpanthenol, DEX042
Primary DI / UDI-DI
05213010813453
Basic UDI-DI
803413527THENOPHTHLMCGLST
EMDN Code
Q02030399 Ophthalmology, viscoelastic fluids - other
Device Class
Class IIb
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
IT-MF-000026977

Other devices from NTC Srl

See all devices from NTC Srl →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (1)

  • EUDAMED d70d5f42-6935-47f9-95c8-6c92e0d2c0d8 61 fields · synced 23 Oct 2026