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Kardiostymulator zewnętrzny MIP 801

by Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny

Ref 05904815536400Model MIP-801

Active European Union

CE MDR

Valid until

12 Dec 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TUV NORD Polska Sp. z o.o

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number59048155364_MIP801YH Basic UDI-DI 05904815536400UDI-DIDate6 Mar 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

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

    Quality management system EU MDR

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Kardiostymulator Zewnętrzny MIP-801
Model / Reference
MIP-801, 05904815536400
Primary DI / UDI-DI
05904815536400
Basic UDI-DI
59048155364_MIP801YH
Direct Marketing DI
05904815536400
EMDN Code
C020299 Cardiac temporary stimulation devices (with or without active substances) - other
Device Class
Class IIb
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000001669

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Properties

  • 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