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Labomed

by Labotech Microscopes India Pvt. Ltd. India EUDAMED

Ref 6128600-796Model 6128000 / 6128600

EMDN Z12020703

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8908006463612-PR-CCSLP Basic UDI-DIDate28 Mar 2023RegisteredStatusActive

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
Prima C/CS Colposcope
Model / Reference
6128000 / 6128600, 6128600-796
Primary DI / UDI-DI
08908006463619
Basic UDI-DI
8908006463612-PR-CCSLP
Direct Marketing DI
08908006463619
EMDN Code
Z12020703 Colposcopes
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 7fde398c-57a0-40c0-a03a-2195a8cc67c9 61 fields · synced 22 Oct 2026