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Focus 640

by Enhanced Vision Systems, Inc EUDAMED

Active European Union

Ref F640-UMMS

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850018343FOCUS6W6 Basic UDI-DIDate19 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
F640-UMMS
Primary DI / UDI-DI
08500183433982
Basic UDI-DI
0850018343FOCUS6W6
Direct Marketing DI
08500183433982
EMDN Code
Y2199 Communication and information management aids - other
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000037120
Authorised representative
Optelec Nederland B.V. NL-AR-000035613

Other devices from Enhanced Vision Systems, Inc

Properties

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