ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk
PL-MF-000029550 · Poland · Niemce
ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk is registered in the European database on medical devices as a manufacturer, with 139 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 139 |
|---|
Most frequent device types declared: A1, A2, A3, A3.5 , B1, B2, C2, D2, D3, T, OA2, OA3, A1, A2, A3, A3.5,A4, OA2, White, Black, Red, Yellow, Orange, Green, Pink, Blue, Purple, A, B, C, Gingival, White, Internal, External.
Among these devices, 113 are declared implantable.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 139 |
| Country of registration | Poland |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.