Elitex Prodexim SRL
RO-MF-000033014 · Romania · Ceuasu de Campie
Elitex Prodexim SRL is registered in the European database on medical devices as a manufacturer, with 43 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 43 |
|---|
Devices declared under this manufacturer
- Double adapter (aluminium)
- Double adapter with adjustment core
- Eccentric adapter with adjustment core support
- Foot adapter (aluminium)
- Lamination anchor with adjustment core for transtibial socket
- Orthotic knee joint with lock for children
- Single adapter
- Single-axis knee joint
- Socket adapter with adjustment core
- Socket adapter with adjustment core support (aluminium)
- Socket adapter with rotatable adjustment core
- Solid ankle foot
Showing 12 of 43 declared devices.
Catalogue references include A31, A36, B10, B30-ALU, B51, C10-ALU.
European nomenclature codes declared: Y062415, Y06121201, Y062403, Y062409.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 43 |
| Country of registration | Romania |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 43 |
|---|---|
| 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. Elitex Prodexim SRL was not found in either the U.S. or the Canadian register.