PROMOCIÓN OPTOMÉTRICA DE BURGOS, S.L.
ES-MF-000055881 · Spain · Sotopalacios (Burgos)
PROMOCIÓN OPTOMÉTRICA DE BURGOS, S.L. is registered in the European database on medical devices as a manufacturer, with 95 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 95 |
|---|
Devices declared under this manufacturer
- Barras de Lectura R/V (10x15)
- Carta A.R.B. nº 2
- Carta A.R.B. nº 3
- Carta Ortóptica
- Cartas de Hart Letras, V.P.
- Cartas de Hart de Números y Letras, V.P.
- Gafa Rojo/Verde Pediátrica
- Oclusores Binasales
- Optotipos Infantiles Palomar (multidistancia).
- Pelota de Marsden Roja
- Separador Blanco (Septum)
- Tarjeta Diana Infantil (Dibujos)
Showing 12 of 95 declared devices.
Catalogue references include 3001, 9525-C, 9528-R, 9535, 9538N-2, 9539-2.
European nomenclature codes declared: Z1212012080.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 95 |
| 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 | 95 |
|---|---|
| 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. PROMOCIÓN OPTOMÉTRICA DE BURGOS, S.L. was not found in either the U.S. or the Canadian register.