Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny
Active in EUDAMEDPolandfrom SRN EUDAMED SRN PL-MF-000001669
- Devices
- 6
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
Kardiostymulator zewnętrzny MIP 801 Ref 05904815536400
Bieżnia ERT-200 Ref 05904815554602
Cardiv Ref 05904815540032
System MONAKO Ref 05904815542302
Cykloergometr ERM-200 Ref 05904815563604
Peleton Ref 05904815540025
Company details
- EUDAMED SRN
- PL-MF-000001669
- EU VAT number
- 6750000088
- EUDAMED status
- Active
- EUDAMED registered name
- Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny
- EUDAMED abbreviated name
- Łukasiewicz-KIT
- Registered address
- 73, Zakopiańska, 30-418, Kraków, Poland
- Website
- kit.lukasiewicz.gov.pl
- [email protected]
- Phone
- +48 32 12 261 83 24
- PRRC contact
- Ewelina Sobotnicka
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 12 Dec 2028
TUV NORD Polska Sp. z o.o 2274 1 certificate
- TNP/MDR/0045/555/2025 Amended
Quality management system EU MDR
- Issued
- 5 Jan 2026
- Expires
- 12 Dec 2028
- Reason
- Mnf data change
From the company website
Łukasiewicz – Krakowski Instytut Technologiczny was created on 1 April 2020 from the merger of two ZQXK002KQZch InstytutZ: Łukasiewicz – Instytutu Foundry and Łukasiewicz – Instytutu Advanced Manufacturing Technology. 1 January 2023 part of Łukasiewicz – KIT became Łukasiewicz – Instytut Technology and Medical Equipment based in Zabrze.
What Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny makes
The manufacturer produces external pacemakers, including the MIP 801 model, as well as cardiac rehabilitation equipment such as treadmills (ERT-200), cycle ergometers (ERM-200), and systems for monitoring and exercise testing (CARDIV, MONAKO). Additional offerings include a stationary bike for home use (PELETON) and devices for stress testing and cardiac assessment.
These devices are classified under EU regulations as Class IIa and Class IIb medical devices, with all relevant products listed in the EUDAMED database. The manufacturer operates under the regulatory framework of the European Union, where its headquarters and development facilities are based in Poland.
Frequently asked questions
How many devices does Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny have in the registry?
The registry currently lists 6 devices for Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny's devices?
Among its 6 most recently registered devices, Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny has devices listed in EUDAMED (6 devices).
What risk classes do Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny's devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny?
EUDAMED lists 1 certificate for Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny (quality management system) under MDR. The most recent was issued on 2026-01-05.
What are the newest devices from Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny in the registry?
The most recently registered devices listed for Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny include Kardiostymulator zewnętrzny MIP 801, Bieżnia ERT-200, CARDIV and System MONAKO.