DIABETYK24 SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
PL-MF-000054449 · Poland · Opacz-Kolonia
DIABETYK24 SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 72 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 72 |
|---|
Devices declared under this manufacturer
- HOLDI plastry ochronne na sensor Dexcom G7 i Dexcom One+
- HOLDI plastry ochronne na sensor FreeStyle Libre 2
- HOLDI plastry ochronne na sensor FreeStyle Libre 3
- HOLDI plastry ochronne na sensor Guardian 4
Showing 12 of 72 declared devices.
Catalogue references include color MIX, honey yellow, lavender dream, onyx black, pink lemonade, sky blue.
European nomenclature codes declared: M0599.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 72 |
| 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 | 72 |
|---|---|
| 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. DIABETYK24 SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ was not found in either the U.S. or the Canadian register.