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Sodium Hyaluronate Ophthalmic Solutions

by Bio-Tech Vision Care Pvt. Ltd. EUDAMED

Active European Union

Ref BIO-HYALUR PLUS 1.6ml PFS

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890609220HAOSGV Basic UDI-DIDate2 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Device Name
Sodium Hyaluronate Ophthalmic Solutions
Model / Reference
BIO-HYALUR PLUS 1.6ml PFS
Primary DI / UDI-DI
08906092200163
Basic UDI-DI
890609220HAOSGV
EMDN Code
Q02030301 Ophthalmology, hyaluronic acid and derivatives
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
IN-MF-000008482
Authorised representative
Biotech Europe Meditech Inc Limited IE-AR-000004696

Other devices from Bio-Tech Vision Care Pvt. Ltd.

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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