TRANSCENDENCIAS COMERCIALES, S.L.
ES-MF-000006640 · Spain · ASTIGARRAGA
TRANSCENDENCIAS COMERCIALES, S.L. is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 11 |
|---|
Most frequent device types declared: Z-02, Z-04, Z-05, Z-09, Z-10.
Among these devices, 4 are declared active.
Devices declared under this manufacturer
- 8mm Gravity Hydrokit
- Gravity 10mm inflow / Hydrokit with limiter
- HC-1
- HC-1 CLASSIC
- HC-2000
- HC-2000 CLASSIC
- Hydrokit with limiter
- Large Hydrokit
- Segmented Hose / Hydrokit with limiter
- Segmented Hose / Large Hydrokit
- Small Hydrokit
Catalogue references include Z-04, Z-05, Z-09, Z-10, Z-11, Z-13.
European nomenclature codes declared: A030499, A99.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Transcendencias Comerciales S.L (ES) · FDA 3005346382 |
| Devices in EUDAMED | 11 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 11 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | TRANSCENDENCIAS COMERCIALES S.L. |
North American profile: Both markets. TRANSCENDENCIAS COMERCIALES, S.L. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
059/MDR | amended | 2027-11-21 |