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OPTICA AQUOS Krople Do Oczu (Sodium Hyaluronate Eye Drops 0.4%w/v) -10ml

by Stericon Pharma Pvt.ltd

Ref 10ml

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8905702HAED57 Basic UDI-DI 08905702009240UDI-DIDate7 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Sterile Eye Drops - Sodium Hyaluronate Eye Drops
Model / Reference
10ml
Primary DI / UDI-DI
08905702009240
Basic UDI-DI
8905702HAED57
Direct Marketing DI
08905702009240
EMDN Code
Q02030206 Eye lubricant solutions
Device Class
Class IIb
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
IN-MF-000028275
Authorised representative
MYM SOPORTE TECNICO Y DE CALIDAD, S.L. ES-AR-000017300

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Properties

  • 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