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Optimel Manuka+ Dry Eye Drops

by Melcare Biomedical Pty Ltd Australia EUDAMED

Ref M0344

EMDN M040305

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09343345000344 Basic UDI-DIDate20 Apr 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 24 Oct 2026

Device Name
Honey Product Family
Model / Reference
M0344
Primary DI / UDI-DI
09343345000344
Basic UDI-DI
B-09343345000344
EMDN Code
M040305 Ophthalmic dressings in the form of eye drops/gel/creams
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
AU-MF-000036955
Authorised representative
MDSS GmbH DE-AR-000005430

From the manufacturer

Manufacturer's product page: Optimel Manuka+ Dry Eye Drops

Other devices from Melcare Biomedical Pty Ltd

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 5ed5f37c-bc92-4d47-8231-869181265fdc 61 fields · synced 24 Oct 2026