Skip to content

Ot-4200

by Nidek SA EUDAMED

Active European Union

Ref HUC4000Model Consultation Unit OT-4200

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number37008623UCO002BH Basic UDI-DIDate6 Jul 2022RegisteredStatusActive

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  • Withdrawn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
Consultation Unit OT-4200, HUC4000
Primary DI / UDI-DI
03700862300061
Basic UDI-DI
37008623UCO002BH
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000493

Other devices from Nidek SA

See all devices from Nidek SA →

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