Biosphere Medical SA
FR-MF-000005250 · France · Roissy-en-France
Biosphere Medical SA is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class I | 19 |
|---|
Most frequent device types declared: Embosphere®, EmboGold®, EmboCube®, HepaSphere™.
Among these devices, 19 are declared sterile, 19 implantable.
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 | Similar name found — unverified |
|---|---|
| Matched entry | BIOSPHERE MEDICAL, S.A. (FR) · FDA 9615728 |
| Devices in EUDAMED | 19 |
| Country of registration | France |
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.