ASTAR spółka z ograniczoną odpowiedzialnością
PL-MF-000010564 · Poland · Bielsko-Biała
ASTAR spółka z ograniczoną odpowiedzialnością is registered in the European database on medical devices as a manufacturer, with 48 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 32 |
|---|---|
| Class IIb | 16 |
Most frequent device types declared: 827, 825, 815, 500I, 501I, 700I, 701I, 300A, 301A, 200A, 201A.
Among these devices, 30 are declared active.
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 | 48 |
| 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1962094-1 | supplemented | 2028-08-01 |