SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa
PL-MF-000010592 · Poland · Sulejówek
SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa is registered in the European database on medical devices as a manufacturer, with 1 462 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 490 |
|---|---|
| Class IIb | 972 |
Among these devices, 1 462 are declared sterile.
Devices declared under this manufacturer
- Kaniula wewnętrzna
- Rurka dooskrzelowa lewostronna
- Rurka dooskrzelowa lewostronna, tracheostomijna
- Rurka dooskrzelowa prawostronna
- Rurka dooskrzelowa prawostronna, tracheostomijna
- Rurka intubacyjna bez mankietu
- Rurka intubacyjna z mankietem
- Rurka tracheostomijna KAN bez mankietu
- Rurka tracheostomijna KAN z mankietem
- Rurka tracheostomijna SUMINI bez mankietu
- Rurka tracheostomijna SUMINI z mankietem
- Rurka tracheostomijna SuMRI bez mankietu
Showing 12 of 1 462 declared devices.
Catalogue references include 08-5095, 12-5010, 22-7010, 33-6510, 45-1002, 46-1030.
European nomenclature codes declared: R0105010101, R0105020101, R010503, R01030201, R01030101, R0105020102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 1 462 |
| 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 | 1 462 |
|---|---|
| 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. SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1023926-1 | issued | 2029-04-08 |