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Proluxx Duo

by NTC Srl Italy EUDAMED

Ref PES061Model Solution for ocular spray based on sodium hyaluronate and Perilla, preservative free

EMDN Q02030399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803413527TD072SLTNFRCLRNJ Basic UDI-DIDate12 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Solution for ocular spray based on sodium hyaluronate and Perilla, preservative free, PES061
Primary DI / UDI-DI
03857500055330
Basic UDI-DI
803413527TD072SLTNFRCLRNJ
EMDN Code
Q02030399 Ophthalmology, viscoelastic fluids - other
Device Class
Class IIb
Market of Registration
Slovenia

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
  • CMR Substance
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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 1981656e-5a28-48bc-a252-b9a3882688a8 61 fields · synced 24 Oct 2026