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Sodium Hyaluronate Ophthalmic Solutions

by Bio-Tech Vision Care Pvt. Ltd. India EUDAMED

Ref VISCOTECH 1% EMDN Q02030301

Regulatory status

as of 26 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  • Withdrawn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

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Sodium Hyaluronate Ophthalmic Solutions
Model / Reference
VISCOTECH 1%
Primary DI / UDI-DI
08027864012002
Basic UDI-DI
890609220HAOSGV
EMDN Code
Q02030301 Ophthalmology, hyaluronic acid and derivatives
Device Class
Class IIb
Market of Registration
Italy

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.

See all devices from Bio-Tech Vision Care Pvt. Ltd. →

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 08027864012002|890609220HAOSGV 61 fields · synced 25 Oct 2026