ABINOX Piotr Szłapka
PL-MF-000043281 · Poland · Kiełczewo
ABINOX Piotr Szłapka is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 7 |
|---|
Most frequent device types declared: 1-001, 1-002, 1-010/1, 1-010/2, 1-010/3, 1-010/4, 1-030/1, 1-030/2, 1-030/3, 1-030/4, 1-030/5.
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 | 7 |
| 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.