FDA Device Establishments · JSON-LD · Markdown
FEI 3008331339 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3008331339 |
|---|---|
| Owner / Operator | Plastiflex Healthcare Division of Plastiflex Group NV (#10031967) |
| Address | Buntjesstraat 13, Paal Beringen Limburg, B-3583, BE |
| Mandatory US Agent | Qserve Group US Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | BZE |
| Regulation § (21 CFR) | 868.5270 |
| Proprietary names | Comfortline Heated Tubing HHU19018WT0033CK; Hybernite ROC US HHU19018WT0ECBCK; Replacement Comfortline Heated Tubing HRU19018WT0033GI; Hybernite HBT White HRN19018WT0ECWGC |
Source: openFDA. Public-domain (CC0).