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Bio Decalin

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

Ref BIO DECALINModel Silicone Oil 1000cSt

EMDN Q02030205

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890609220OEXJ Basic UDI-DIDate27 Oct 2025RegisteredStatusActive

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
Silicone Oil
Model / Reference
Silicone Oil 1000cSt, BIO DECALIN
Primary DI / UDI-DI
08906092200019
Basic UDI-DI
890609220OEXJ
EMDN Code
Q02030205 Ophthalmic surgery, perfluorocarbons pure and combined with other substances
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.

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 ac12a298-d647-43c9-9f93-d6bad02e5d86 61 fields · synced 22 Oct 2026