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Labomed

by Labotech Microscopes India Pvt. Ltd. India EUDAMED

Ref 6121035PModel 6121025,6121035P,6122015 EMDN Z12011101

Overview

Labomed is a Class I medical device that provides precise binocular head measurements, ideal for ophthalmic devices and procedures. It offers accurate and reliable measurements, ensuring consistent results in clinical settings.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890616845BINOCULAR-HEADPM Basic UDI-DIDate6 Apr 2023RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Model / Reference
6121025, 6121035P, 6122015
Primary DI / UDI-DI
08906168450027
Basic UDI-DI
890616845BINOCULAR-HEADPM
EMDN Code
Z12011101 Operative microscopes
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
IN-MF-000033373
Authorised representative
Labomed Europe b.v. NL-AR-000022889

Other devices from Labotech Microscopes India Pvt. Ltd.

See all devices from Labotech Microscopes India Pvt. Ltd. →

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 234f926c-158d-448f-816b-56a8f63ad8e9 61 fields · synced 24 Oct 2026