Bioretec Ltd.
FI-MF-000001328 · Finland · Tampere
Bioretec Ltd. is registered in the European database on medical devices as a manufacturer, with 349 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 176 |
|---|---|
| Class IIa | 173 |
Most frequent device types declared: B-ISC-4502, B-II-1624, B-AS-4570, B-II-0830B, B-DI-0515.
Among these devices, 178 are declared sterile, 176 implantable, 170 reusable, 1 with a measuring function.
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 | Registered with FDA |
|---|---|
| Matched entry | Bioretec Ltd. (FI) · FDA 3005536892 |
| Devices in EUDAMED | 349 |
| Country of registration | Finland |