Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny
PL-MF-000001669 · Poland · Kraków
Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 5 |
|---|---|
| Class IIb | 2 |
Most frequent device types declared: ERM-200, ERT-200, MIP-801.
Among these devices, 7 are declared active, 6 with a measuring function.
Devices declared under this manufacturer
- Bieżnia ERT-200
- CARDIV
- Cykloergometr ERM-200
- Kardiostymulator zewnętrzny MIP 801
- PELETON
- PELETON-CARDIV
- System MONAKO
Catalogue references include 05904815536400, 05904815540018, 05904815540025, 05904815540032, 05904815542302, 05904815554602.
European nomenclature codes declared: Z12050701, Z129003, C020299, Z12080101, Z129006.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| Country of registration | Poland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
TNP/MDR/0045/555/2025 | amended | 2028-12-12 |