BEUDAMED
    MDR MDR QMS Amended Expired

    TNP/MDR/0005/0555/2022

    Manufacturer: Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny
    Basic UDI-DIs
    0
    Scopes
    10
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    0
    Revision
    Ver. 02
    178
    Expired 178 days ago
    Expiry: December 12, 2025

    Basic Information

    Number
    TNP/MDR/0005/0555/2022
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    June 1, 2023
    Expiry Date
    December 12, 2025 Expired
    Revision
    Ver. 02
    Manufacturer
    Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny

    Certificate Lifecycle

    June 1, 2023 December 12, 2025

    Scopes

    10 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    System monitorowania parametrów fizjologicznych w kardiologicznym treningu rehabilitacyjnym i w badaniu wysiłkowym. / Monitoring system for physiological parameters in cardiac rehabilitation training and cardiac stress testing.

    Quality Procedure Scope

    Device Group Class IIb

    Kardiostymulator zewnętrzny / External Pacemaker

    Quality Procedure Scope

    Device Group Class IIa

    Cykloergometr / Cycloergometer

    Quality Procedure Scope

    Device Group Class IIa

    Bieżnia / Treadmil

    Quality Procedure Scope

    Device Group Class IIb

    Centralny system monitorowania płodu i noworodka / Centralized fetal and neonatal monitoring system

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIa

    Preceding Certificates

    TNP/MDR/0005/0555/2022 Issued
    Issued: December 13, 2022 Expires: December 12, 2025

    Basic UDI-DIs

    This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.