Skip to content

Kaleos

by Kaleos Eyehunters Slu EUDAMED

Active European Union

Ref 394435667212, 394435667213, 394435667211Model Montura Graduada Combinado, Montura Graduada Metal, Montura Graduada Acetato

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number84356672394435667212C5 Basic UDI-DIDate5 Mar 2024RegisteredStatusActive

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  • Withdrawn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
Montura Graduada Combinado, 394435667212, Montura Graduada Metal, 394435667213, Montura Graduada Acetato, 394435667211
Primary DI / UDI-DI
84356672394435667212C5, 84356672394435667213C7, 84356672394435667211C3
Basic UDI-DI
84356672394435667212C5, 84356672394435667213C7, 84356672394435667211C3
Direct Marketing DI
84356672394435667212C5
84356672394435667213C7
84356672394435667211C3
EMDN Code
Q02100203, Q02100201, Q02100202
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000039443

Other devices from Kaleos Eyehunters Slu

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