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Helenvision Pure

by NTC Srl Italy EUDAMED

Ref HYS277Model Ophtalmic solution with sodium hyaluronate 0,1% - 0,2%, 0,4% - preservative free EMDN Q02030301

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803413527TD050PHTHLMCSLD3 Basic UDI-DIDate12 May 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  • Withdrawn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 24 Oct 2026

Model / Reference
Ophtalmic solution with sodium hyaluronate 0, 1% - 0, 2%, 0, 4% - preservative free, HYS277
Primary DI / UDI-DI
05213010813484
Basic UDI-DI
803413527TD050PHTHLMCSLD3
EMDN Code
Q02030301 Ophthalmology, hyaluronic acid and derivatives
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 1ff5d8c2-de23-46a1-9b67-ffb72da82b4b 61 fields · synced 24 Oct 2026