Bandtex Grup S.R.L.
RO-MF-000004081 · Romania · Saucesti
Bandtex Grup S.R.L. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 8 |
|---|
Most frequent device types declared: BTX4040100, FT 10cm/10M.
Devices declared under this manufacturer
- Sanrotex Medical
Catalogue references include BTX05050, BTX05100, BTX08050, BTX10100, BTX101008100, BTX15100.
European nomenclature codes declared: M030101, M0201010102, M0201020102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| 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 | 8 |
|---|---|
| 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. Bandtex Grup S.R.L. was not found in either the U.S. or the Canadian register.