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Op'cover

by Arcadophta France EUDAMED

Ref 401

EMDN Q02030399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number376013064BZIC000010VH Basic UDI-DIDate27 Oct 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

Device Name
Op Cover
Model / Reference
401
Primary DI / UDI-DI
13760130640753
Basic UDI-DI
376013064BZIC000010VH
EMDN Code
Q02030399 Ophthalmology, viscoelastic fluids - other
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000001661

Other devices from Arcadophta

See all devices from Arcadophta →

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 7d2cac22-44d2-47c5-b75a-d05729a47536 61 fields · synced 22 Oct 2026