AMBELIO
FR-MF-000001631 · France · La Mézière
AMBELIO is registered in the European database on medical devices as a manufacturer, with 55 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 55 |
|---|
Most frequent device types declared: Attelle de poignet main Handbreizh®, Attelle de poignet pouce HandTbreizh, Ceinture de soutien lombaire Lumbar breizh, Epaulière coude au corps Y, KIT ABDOBACK.
Devices declared under this manufacturer
- KIT ABDOBACK T1
- KIT ABDOBACK T2
- KIT Echarpe coude au corps Y T1
- KIT Echarpe coude au corps Y T3
- KIT KNEEFREEZ PO 2US
- KIT KNEEFREEZ PO PRESSO TSML
- Kit Attelle Genou 3P FREEZSNOW® TL
- Kit HandTbreizh Gauche TL
- Kit HandTbreizh modèle droit TL
- Kit Handbreizh TM
- Kit KNEEFREEZ PO PRESSO 2US TXL/2XL
- Kit KNEEFREEZ® Sans boite
Showing 12 of 55 declared devices.
European nomenclature codes declared: Y061209, Y060499, Y060613, M9001, Y060621, Y060309.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 55 |
| 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 | 55 |
|---|---|
| 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. AMBELIO was not found in either the U.S. or the Canadian register.