OrtoProfil Prod Romania SRL
RO-MF-000000526 · Romania · Targu Mures
OrtoProfil Prod Romania SRL is registered in the European database on medical devices as a manufacturer, with 499 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 499 |
|---|
Devices declared under this manufacturer
- ProfiTEX Lombosacral-panza VI
- ProfiTEX PodoCare KID 21
- ProfiTEX PodoCare KID 38
- ProfiTEX PodoCare ORTOMED EC34
- ProfiTEX PodoCare ORTOMED EC46
- ProfiTEX PodoCare ORTOMED PP27
- ProfiTEX PodoCare RIGIDUSM 47
- ProfiTEX PodoCare Sport S F 29
- ProfiTEX PodoCare Sport S T 27
- ProfiTEX PodoCare Sport S T 36
- ProfiTEX PodoCare Sport SBI 41
- ProfiTEX PodoCare Sport TT 38
Showing 12 of 499 declared devices.
Catalogue references include 4T.S-200-EC-34, 4T.S-200-EC-46, 4T.S-200-PP-27, 4T.T-20-38, 4T.T-20-41, 4X.CO-23-VI.
European nomenclature codes declared: Y061203, Y060308, Y063303, Y060315, Y060612, Y061215.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 499 |
| 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 | 499 |
|---|---|
| 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. OrtoProfil Prod Romania SRL was not found in either the U.S. or the Canadian register.