TRICOMED S.A.
PL-MF-000002483 · Poland · Łódź
TRICOMED S.A. is registered in the European database on medical devices as a manufacturer, with 257 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 181 |
|---|---|
| Class I | 54 |
| Class IIa | 22 |
Most frequent device types declared: 10x10 cm, 20x20 cm, 15x15 cm, dostosowany, MP 200x300 mm.
Among these devices, 235 are declared sterile, 198 implantable, 4 reusable.
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 | 257 |
| 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 |
|---|---|---|
1434-MDR-009/2024 | issued | 2029-07-11 |
1434-MDR-008/2024 | amended | 2029-07-11 |
1434-MDR-007/2024 | issued | 2029-07-11 |