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: EmboCube®, EmboGold®, Embosphere®, HepaSphere™.
Among these devices, 19 are declared sterile, 19 implantable.
Devices declared under this manufacturer
- EmboCube®
- EmboGold®
- Embosphere®
- HepaSphere™
Showing 12 of 19 declared devices.
Catalogue references include EC2550/EU, EC5050/EU, S020GH/EUA, S1020EG/EUA, S120EG/EUA, S410GH/EUA.
European nomenclature codes declared: C010402020303.
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; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 19 |
|---|---|
| Found in the U.S. device database | 14 |
| Share | 73.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIOSPHERE MEDICAL INC. |