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System MONAKO

by Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny Poland EUDAMED

Ref 05904815542302

EMDN Z12080101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number59048155423_MONAKO56 Basic UDI-DIDate6 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • TNP/MDR/0045/555/2025 Amended

    Quality management system EU MDR

    Notified body
    TUV NORD Polska Sp. z o.o 2274
    Issued
    5 Jan 2026
    Expires
    12 Dec 2028
    Reason
    Mnf data change

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
05904815542302
Primary DI / UDI-DI
05904815542302
Basic UDI-DI
59048155423_MONAKO56
Direct Marketing DI
05904815542302
EMDN Code
Z12080101 Foetal monitors
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000001669

Other devices from Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny

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 33db3f69-6ec0-4735-96af-031c509a5bd7 61 fields · synced 22 Oct 2026