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Cykloergometr ERM-200

by Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny Poland EUDAMED

Ref 05904815563604Model ERM-200 EMDN Z129003

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberTNP/MDR/0045/555/2025 Date5 Jan 2026IssuedStatusActive expires 12 Dec 2028

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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 24 Oct 2026

Model / Reference
ERM-200, 05904815563604
Primary DI / UDI-DI
05904815563604
Basic UDI-DI
59048155636_ERM200YF
Direct Marketing DI
05904815563604
EMDN Code
Z129003 Cycles for physiotherapy and/or diagnostic uses
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000001669

Other devices from Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny

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    Class IIb

  • Peleton

    Class IIa

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED e9bd8175-6bfc-48b3-9933-d1d7db1a939f 61 fields · synced 24 Oct 2026