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Sodium Hyaluronate Ophthalmic Solutions

by Bio-Tech Vision Care Pvt. Ltd. 10 variants

Ref BIO-HYALUR EV 1.6ml PFS

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890609220HAOSGV Basic UDI-DI 08906092200262UDI-DIDate2 Jul 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  • Withdrawn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
Sodium Hyaluronate Ophthalmic Solutions
Model / Reference
BIO-HYALUR EV 1.6ml PFS
Primary DI / UDI-DI
08906092200262
Basic UDI-DI
890609220HAOSGV
EMDN Code
Q02030301 Ophthalmology, hyaluronic acid and derivatives
Device Class
Class IIb
EU 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.

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

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