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Colposcope

by Science Engineering Center "SCANER" LLC Ukraine EUDAMED

Ref МК-200-АModel MK-200

EMDN Z12020703

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number482029653MKUD Basic UDI-DIDate15 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Colposcope
Model / Reference
MK-200, МК-200-А
Primary DI / UDI-DI
04820296530083
Basic UDI-DI
482029653MKUD
EMDN Code
Z12020703 Colposcopes
Device Class
Class I
Special Device Type
Software
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
UA-MF-000049340
Authorised representative
AFINA, spol.s r.o. CZ-AR-000000584

Other devices from Science Engineering Center "SCANER" LLC

See all devices from Science Engineering Center "SCANER" LLC →

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 c0d44cf1-e3ce-497a-ba0e-7c1012dedc17 61 fields · synced 23 Oct 2026