Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny

Certificate TNP/MDR/0045/555/2025

Rev. ver. 02Amended

Valid until: Dec 12, 2028

Certificate TNP/MDR/0045/555/2025 is a valid Quality management system issued to Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny and registered in EUDAMED. Valid until December 12, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: TNP/MDR/0045/555/2025
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 2274TNP/MDR/0045/555/2025ver. 02

Validity

Issued: Jan 5, 2026
Valid from: Jan 5, 2026
Valid until: Dec 12, 2028

Notified body

Notified body: TUV NORD Polska Sp. z o.o
Notified body SRN: 2274
Notified body country: Poland

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Basic UDI-DI data and Class IIb

History

Status changes

Amended

Supersedes

TNP/MDR/0045/555/2025Quality management systemIssuedDec 5, 2025 → Dec 12, 2028

Scope coverage

Class IIa6Class IIb4

10 scopes

Kardiostymulator zewnętrzny/ External Pacemaker
Class IIb
Cykloergometr / Cycloergometer
Class IIa
Bieżnia/ Treadmill
Class IIa
Centralny system monitorowania płodu i noworodka/ Centralized fetal and neonatal monitoring system
Class IIb
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
Class IIa
DEVICE
Class IIb
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIb
DEVICE
Class IIa

Documents

LanguagesENPL

Scope coverage

Class IIa6Class IIb4

10 scopes

Kardiostymulator zewnętrzny/ External Pacemaker
Class IIb
Cykloergometr / Cycloergometer
Class IIa
Bieżnia/ Treadmill
Class IIa
Centralny system monitorowania płodu i noworodka/ Centralized fetal and neonatal monitoring system
Class IIb
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
Class IIa
DEVICE
Class IIb
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIb
DEVICE
Class IIa

Certificate TNP/MDR/0045/555/2025

Overview

Validity

Notified body

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate TNP/MDR/0045/555/2025

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer

Covered devices