PROMECHI, S.L.
ES-MF-000010973 · Spain · ALACUAS - VALENCIA
PROMECHI, S.L. is registered in the European database on medical devices as a manufacturer, with 124 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 122 |
|---|---|
| Class IIa | 2 |
Most frequent device types declared: CANULA DE LARINGECTOMIA PLATA FENESTRADA Nº 3 - 9 x 55 mm, CANULA DE PLATA FONATORIA Nº 4 - 10 x 68 mm, CANULA DE PLATA FONATORIA Nº 7 - 13 x 80 mm, CANULA DE PLATA LARGO ESPECIAL Nº 00 -5 x 88 mm - 2 PIEZAS, CANULA DE PLATA LARGO ESPECIAL Nº 3 - 9 x 97 mm.
Devices declared under this manufacturer
- CANULA DE LARINGECTOMIA PLATA FENESTRADA Nº 3 - 9 x 55 mm
- CANULA DE LARINGECTOMIA PLATA Nº 6 - 12 x 60 mm
- CANULA DE LARINGECTOMIA PLATA Nº 8 - 14 x 60 mm
- CANULA DE PLATA FONATORIA Nº 4 - 10 x 68 mm
- CANULA DE PLATA FONATORIA Nº 7 - 13 x 80 mm
- CANULA DE PLATA LARGO ESPECIAL Nº 00 -5 x 88 mm - 2 PIEZAS
- CANULA DE PLATA LARGO ESPECIAL Nº 3 - 9 x 97 mm
- CANULA DE PLATA LARGO ESPECIAL Nº 8 - 14 x 107 mm) - 2 PIEZAS
- CANULA DE TRAQUEOTOMIA DE PLATA Nº 8 - 2 PIEZAS - 14 x 80 mm
- CANULA DE TRAQUEOTOMIA PLATA FENESTRADA Nº 00 - 5 x 42 mm
- CANULA DE TRAQUEOTOMIA PLATA FENESTRADA Nº 7 - 13 x 80 mm
- CÁNULA DE SILICONA FENESTRADA Nº 8 - 14 x 63 mm
Showing 12 of 124 declared devices.
Catalogue references include FE00, FE07, FO04, LA03F, LE00-2P, LE01F-2P.
European nomenclature codes declared: R010599, M040203.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 124 |
| Country of registration | Spain |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 124 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. PROMECHI, S.L. was not found in either the U.S. or the Canadian register.