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Diffuser Kit eVO 300

by Labo America Inc. United States EUDAMED

Ref 8125070

EMDN Z12120108

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number81017855ACCESSORIESSLIT7C Basic UDI-DIDate25 Sep 2024RegisteredStatusActive

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
Accessories & Spares for Slit Lamp
Model / Reference
8125070
Primary DI / UDI-DI
00810178550500
Basic UDI-DI
81017855ACCESSORIESSLIT7C
Direct Marketing DI
00810178550500
EMDN Code
Z12120108 Slit lamps
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000044352
Authorised representative
Labomed Europe b.v. NL-AR-000022889

Other devices from Labo America Inc.

See all devices from Labo America Inc. →

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 bd7d5998-2083-491e-8713-80f94e6b505b 61 fields · synced 22 Oct 2026