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Helenvision Dual

by bitop AG Germany EUDAMED

Ref 38101Model EED03 EMDN Q02030299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-38101GE Basic UDI-DIDate21 Jul 2025RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Ectoin® Inflammation Reducing Eye Drops 2%
Model / Reference
EED03, 38101
Primary DI / UDI-DI
D-38101GE
Basic UDI-DI
B-38101GE
EMDN Code
Q02030299 Ophthalmology, liquid fluids - other
Device Class
Class IIa
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
DE-MF-000006543

Other devices from bitop AG

See all devices from bitop AG →

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 d2f6f5c8-0ad4-4130-9d41-b350a7622d9c 61 fields · synced 22 Oct 2026