HEMODIA SAS
FR-MF-000007191 · France · LABEGE
HEMODIA SAS is registered in the European database on medical devices as a manufacturer, with 361 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 360 |
|---|---|
| Class I | 1 |
Most frequent device types declared: CHAMP, CORDON D'ALIMENTATION, CUPULE, INTERFACE PEDALES, TELECOMMANDE.
Among these devices, 168 are declared sterile, 15 active.
Devices declared under this manufacturer
- CH OUA 100x150 F7.5 1/3
- CH OUA 75x160 COUPE A PLAT
- CH SPU 44x60 FT 6 1/3
- Cupule bleue 90ml
- Cupule transparente 90ml
- DOUBLEFLO OUTFLOW TUBE SET
- POWER CORD FOR AUSTRALIA / NEW ZELAND
- RACCORD Y POUR UNIPONCTURE GAM
- RACCORDS DE DIALYSE LG 200 GAM
- REMOTE DOUBLEFLO
- SET BR FISTULE
- SET BR KT DIALYSE
Showing 12 of 361 declared devices.
Catalogue references include 0095_D, 103739, 4161_A, 6565_A, 72205369, 72205765.
European nomenclature codes declared: T020199, F0303, F0299, Z1202110201, A0380, A0399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Hemodia SAS (FR) · FDA 9681574 |
| Devices in EUDAMED | 361 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 361 |
|---|---|
| Found in the U.S. device database | 21 |
| Share | 5.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | HEMODIA SAS |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2021-09-22 |
Licence types: System (2).
Licensed under: DOUBLEFLO INFLOW/OUTFLOW PUMP, DOUBLEFLO INFLOW/OUTFLOW PUMP - 72205776.
North American profile: Both markets. HEMODIA SAS is registered in both the United States and Canada.