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Stella Microscope Cataract

by Labo America Inc. United States EUDAMED

Ref 6219103Model Prima ,Prima Mu, Stella EMDN Z12011101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number81017855OPHSURGICALGR Basic UDI-DIDate25 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Surgical (Operating) Microscope
Model / Reference
Prima, Prima Mu, Stella, 6219103
Primary DI / UDI-DI
00810178550197
Basic UDI-DI
81017855OPHSURGICALGR
Direct Marketing DI
00810178550197
EMDN Code
Z12011101 Operative microscopes
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 2ee68eeb-7e90-49d8-ab13-44dea9a7e239 61 fields · synced 22 Oct 2026