Orthoguard Maciej Tomczuk
PL-MF-000002247 · Poland · Sokołów Podlaski
Orthoguard Maciej Tomczuk is registered in the European database on medical devices as a manufacturer, with 68 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 68 |
|---|
Devices declared under this manufacturer
- Opaska elastyczna stawu kolanowego (XL)
- Opaska elastyczna stawu skokowego (L)
- Opaska elastyczna stawu skokowego (S)
- Opaska elastyczna stawu łokciowego (XL)
- Orteza kończyny dolnej 28 cm (M)
- Orteza kończyny dolnej 28 cm (XL)
- Orteza kończyny dolnej 43 cm (L)
- Orteza kończyny dolnej 43 cm (S)
- Orteza nadgarstka (L, lewa)
- Orteza nadgarstka (M, prawa)
- Orteza nadgarstka (S, lewa)
- Orteza nadgarstka lewa (XL)
Showing 12 of 68 declared devices.
Catalogue references include OG-EAN001, OG-EEL001, OG-EKN001, OG-WA001, OG-WK001, OG-WR002.
European nomenclature codes declared: Y060612, Y06120601, Y060499, Y061209, Y060615.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 68 |
| 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 | 68 |
|---|---|
| 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. Orthoguard Maciej Tomczuk was not found in either the U.S. or the Canadian register.