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BCB Cataract Register

by BCB Medical Oy Finland EUDAMED

Ref 06430078510547 EMDN V92

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberFI23/0000002 Date29 Jul 2026IssuedStatusActive expires 11 Feb 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI23/0000002 Amended

    Quality management system EU MDR

    Notified body
    SGS FIMKO OY 0598
    Issued
    29 Jul 2026
    Expires
    11 Feb 2031
    Valid from
    14 Aug 2026
    Reason
    Mnf data change

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Disease Specific Register
Model / Reference
06430078510547
Primary DI / UDI-DI
06430078510547
Basic UDI-DI
643007851BCBDSR2H
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000002441

Other devices from BCB Medical Oy

See all devices from BCB Medical Oy →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • 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 7eec93a9-9d5d-43f2-a0d5-e998eddd7935 61 fields · synced 22 Oct 2026