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i-Visc 1.4%

by Albomed GmbH Germany EUDAMED

Ref 04522Model Sodium Hyaluronate Intra-Ocular Gel

EMDN Q02030301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42503119SOHY-F-OPHTHA7K Basic UDI-DIDate23 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Sodium Hyaluronate Intra-Ocular Gel, 04522
Primary DI / UDI-DI
04250311909172
Basic UDI-DI
42503119SOHY-F-OPHTHA7K
Direct Marketing DI
04250311909172
EMDN Code
Q02030301 Ophthalmology, hyaluronic acid and derivatives
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000007875

Other devices from Albomed GmbH

See all devices from Albomed GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 96b97e12-eab3-4a8c-a5a8-64187eb3b258 61 fields · synced 22 Oct 2026