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Bio Fluoro

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

Ref MKT1020

EMDN M040302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890602552BIOFLUOROKW Basic UDI-DIDate7 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Bio Fluoro
Model / Reference
MKT1020
Primary DI / UDI-DI
08906025520436
Basic UDI-DI
890602552BIOFLUOROKW
EMDN Code
M040302 Sticks/lancets/strips for ophthalmic use
Device Class
Class I
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 b3df2c95-3fb3-4590-9ffa-b9a2b655088c 61 fields · synced 22 Oct 2026