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Hialix Spray

by Gofarm Sp. z o.o. Sp. k. Poland EUDAMED

Ref ENT14

EMDN Q0399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08435232357516 Basic UDI-DIDate14 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
ENT14
Primary DI / UDI-DI
08435232357516
Basic UDI-DI
B-08435232357516
EMDN Code
Q0399 ENT devices - other
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
PL-MF-000003485

Other devices from Gofarm Sp. z o.o. Sp. k.

See all devices from Gofarm Sp. z o.o. Sp. k. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • 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

Sources (1)

  • EUDAMED 08435232357516|B-08435232357516 61 fields · synced 25 Oct 2026