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: A, B, C, Gingival, White, A1, A2, A3, A3,5 , B1, B2, C2, D2, D3, Incisal, OA2, OA3, Multishade, , A1, A2, A3, A3.5 , B1, B2, C2, D2, D3, T, OA2, OA3, A1, A2, A3, A3.5,A4, OA2, Internal, External.
Among these devices, 113 are declared implantable.
Devices declared under this manufacturer
- BOSTON T
- Dei Etching Gel
- FLOW-ART A1
- FLOW-ART A3.5
- FLOW-COLOR WHITE
- Fibre Composite Medium
- GLAZE
- Gąsienica wewnętrzna
- NEXT A3
- NEXT Blue 0,2 g
- New Extra Bond One
- Perio-flush
Showing 12 of 139 declared devices.
European nomenclature codes declared: Q01010103, Q01010103,Q019006, Q01010199, Q01010402,Q019006, Q01010104, Q01010199,Q019006.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 139 |
| 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 | 139 |
|---|---|
| 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. ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk was not found in either the U.S. or the Canadian register.