MONDIALISTO
FR-MF-000013886 · France · MANOSQUE
MONDIALISTO is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 13 |
|---|
Most frequent device types declared: AMB-DRAP-1, AMB-DRAP-50, CLEAN-SHOE-CPE30-B, CLEAN-SHOE-PP30-B, DRAP-COVER-1.
Devices declared under this manufacturer
- BLOUSE DE SOINS A USAGE UNIQUE
- Drap de transfert à usage unique
- GANTS D'EXAMEN VINYLE - MONDIALISTO
- SURCHAUSSURES CP+PE
- SURCHAUSSURES PLP
- Sac vomitoire à usage unique
- Taie d'oreiller à usage unique
Showing 12 of 13 declared devices.
Catalogue references include AMB-DRAP-1, AMB-DRAP-50, CLEAN-SHOE-CP+PE-50, CLEAN-SHOE-CPE30-B, DRAP-PILLOW100, MD-VINYL-100.
European nomenclature codes declared: T0299, T0208, A060399, T01020201, T0205.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 13 |
| Country of registration | France |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 13 |
|---|---|
| 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. MONDIALISTO was not found in either the U.S. or the Canadian register.