Plastiflex Group NV
BE-MF-000008049 · Belgium · Beringen
Plastiflex Group NV is registered in the European database on medical devices as a manufacturer, with 78 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 78 |
|---|
Most frequent device types declared: Classic : tube models consist of different lengths and diameters, diff, Hybernite : Tube models consist of different lengths, diameter, rib co, The Hybernite RT breathing tubes are combined in breathing sets in a s.
Among these devices, 25 are declared active.
Devices declared under this manufacturer
- CPAP Tubing Sefam
- Classic 19 CPAP Tubing
- Classic 19 US
- Classic 19 White
- Classic PSL 19 Grey
- Classic RT 12 White 10F&15M/10F&15M 1.50m
- Classic RT 12 White 10F&15M/10F&15M 2.00m
- Hybernite RT 12 ex
- Hybernite RT 12 ins
- Hybernite RT12 ex
- S.Box HEATED TUBE
- WM 29067 prismaHYBERNITE
Showing 12 of 78 declared devices.
Catalogue references include HPE15018KT0030GI, HPE15018WT0019GI, HPN12016WT0EPWBB, HPN12016WT0FQWBB, HUE19018GT0030GI, HUN19018WT0SSWGI.
European nomenclature codes declared: R9080, R020107, R02010401.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 78 |
| Country of registration | Belgium |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 78 |
|---|---|
| Found in the U.S. device database | 11 |
| Share | 14.1 % |
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. Plastiflex Group NV was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
24M00174SUP01 | supplemented | 2030-06-17 |