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Zinc-hyaluronate 0.15 % eye drops, solution (Ophylosa®, Richtear®, Curiophtal®, Eyezin®)

by Chemical Works of Gedeon Richter Plc.

Ref 66052600

Active European Union

CE MDR

Valid until

25 Oct 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier mdc medical device certification GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberD1061600039 Date18 Aug 2026IssuedStatusActive expires 25 Oct 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • D1061600039 Active Supplemented

    Technical documentation EU MDR

    Certifier
    mdc medical device certification GmbH 0483
    Issued
    18 Aug 2026
    Expires
    25 Oct 2028
    Reason
    Other

Coverage

1 jurisdiction

Hungary
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

EU market availability

Made available in 1 country, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Hungary since 17 Jan 2024

Last checked 1 Nov 2026.

Specification

EUDAMED

Device Name
Zinc-hyaluronate 0.15 % eye drops, solution (Ophylosa®, Richtear®, Curiophtal®, Eyezin®)
Model / Reference
66052600
Primary DI / UDI-DI
05997001328347
Basic UDI-DI
59970013000014S
EMDN Code
Q02030206 Eye lubricant solutions
Device Class
Class III
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000008014

Properties

  • Sterile
  • Animal Tissues

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No