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Hypaclens Sterile Eye Wash 500ml

by Βιοσερ Α.Ε. Βιομηχανια Παρεντερικων Διαλυματων EUDAMED

Active European Union

Ref 21000091Model Sodium Chloride 0.9% Eye Wash Solution

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-5200702434441NE Basic UDI-DIDate10 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Sodium Chloride 0.9% Eye Wash Solution, 21000091
Primary DI / UDI-DI
D-5200702434441NE
Basic UDI-DI
B-5200702434441NE
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class IIa
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
GR-MF-000013176

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Properties

Show properties
  • Sterile
Other properties (10)
  • 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