ORTOTEX MEDICAL S.L.
ES-MF-000011654 · Spain · ARCHIVEL
ORTOTEX MEDICAL S.L. is registered in the European database on medical devices as a manufacturer, with 192 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 192 |
|---|
Most frequent device types declared: ALMOHADAS, BOTAS, PATUCOS Y TALONERAS, COJINES MÉDICOS ANTIESCARAS, COJINES MÉDICOS DE POSICIONAMIENTO DEL PACIENTE, FUNDAS HIGIÉNICAS PARA CAMA Y CAMILLA.
Devices declared under this manufacturer
- Almohada Cervical Viaje
- Almohada Ocular viscoelástica
- Arnes Chaleco T-2
- Bota Lambskin T-P Derecha
- Cojín 44x44 antideslizante
- Cojín Anillo
- Cojín redondo visco
- Cojín visco gel inteligente coxis
- Cojín viscoelástico anillo
- Funda Colchon Antiácaros 150
- Manopla Antiescaras Grey
- Patuco Antiescaras Salmón Derecho
Showing 12 of 192 declared devices.
Catalogue references include 15725, 23726, 23759, 24731SD, 247331, 26329.
European nomenclature codes declared: V0811, V08030102, V080302, V0804, T030502, Y060624.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 192 |
| 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 | 192 |
|---|---|
| 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. ORTOTEX MEDICAL S.L. was not found in either the U.S. or the Canadian register.