ZBIGNIEW FRĄCKOWIAK MAZBIT PRZEDSIĘBIORSTWO
PL-MF-000039173 · Poland · Środa Wielkopolska
ZBIGNIEW FRĄCKOWIAK MAZBIT PRZEDSIĘBIORSTWO is registered in the European database on medical devices as a manufacturer, with 509 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 509 |
|---|
Devices declared under this manufacturer
- EasyForm
- Wkładki ortopedyczne iORTO ELEGANCE
- Wkładki ortopedyczne iORTO MEDIC
- Wkładki ortopedyczne iORTO MEDIC Wkładki ortopedyczne iORTO MEDIC
- iORTO PROFESSIONAL
- iORTO Professional
Showing 12 of 509 declared devices.
Catalogue references include DYNAMIC SUPPORT (SPACE) IO95, KID (SPACE) IPM52, ORANGE EF-O, SOFT (SPACE) IPM95, iORTO CARE (STANDARD) IO70, iORTO OSTROG (STANDARD) IO73.
European nomenclature codes declared: Y061203.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 509 |
| 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 | 509 |
|---|---|
| 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. ZBIGNIEW FRĄCKOWIAK MAZBIT PRZEDSIĘBIORSTWO was not found in either the U.S. or the Canadian register.