Romans Industrie
FR-MF-000011961 · France · Romans-sur-Isère
Romans Industrie is registered in the European database on medical devices as a manufacturer, with 78 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 78 |
|---|
Most frequent device types declared: CHAUSSURE D AUGMENTATION DU VOLUME DE L AVANT PIED, CHAUSSURE DE DECHARGE DE L AVANT PIED.
Devices declared under this manufacturer
- PAIRE DE IFOS PT 41/42
- PAIRE DE IFOS PT 43/44
- PAIRE DE IFOS PT 45/46
- PERCULIGHT DROIT PT 37/38
- PERCULIGHT GAUCHE PT 43/44
- PERCULIGHT GAUCHE PT 45/46
- Paire de Maia - Pt 40
- Paire de Morphée - Pt 36
- Paire de Morphée - Pt 42
- Perculight Noir Gauche PT 45/46
- Percusoft - Droit - Pt 43/44
- TYPE 1 - Côté Droit - Pointure 35/36
Showing 12 of 78 declared devices.
Catalogue references include Chaussure TYPE 1 - Côté Droit - Pointure 35/36, Chaussure TYPE 1 - Côté Droit - Pointure 41/42, PAIRE DE IFOS PT 41/42, PAIRE DE IFOS PT 45/46, PERCULIGHT GAUCHE PT 45/46, Paire de Morphée - Pt 36.
European nomenclature codes declared: Y063303.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 78 |
| 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 | 78 |
|---|---|
| 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. Romans Industrie was not found in either the U.S. or the Canadian register.