PPS MANUFACTURING
BG-MF-000026135 · Bulgaria · Sofia
PPS MANUFACTURING is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 10 |
|---|
Devices declared under this manufacturer
- Black Label – 3.5G Black Nitrile Examination Gloves
- Safe Care – 3.5G Blue Nitrile Examination Gloves
Catalogue references include PPS-BL-01, PPS-BL-02, PPS-BL-03, PPS-BL-04, PPS-BL-05, PPS-SC-01.
European nomenclature codes declared: T01020204.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 10 |
| Country of registration | Bulgaria |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 10 |
|---|---|
| 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. PPS MANUFACTURING was not found in either the U.S. or the Canadian register.