Skip to content

Optimel Manuka+ Forte Eye Gel

by Melcare Biomedical Pty Ltd Australia EUDAMED

Ref M0337 EMDN M040305

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09343345000337 Basic UDI-DIDate20 Apr 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  • Withdrawn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 · synced 24 Oct 2026

Device Name
Honey Product Family
Model / Reference
M0337
Primary DI / UDI-DI
09343345000337
Basic UDI-DI
B-09343345000337
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+ Forte Eye Gel

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 93e1df29-637a-4629-9dc8-4a081a033b2f 61 fields · synced 24 Oct 2026