FDA Device Establishments · JSON-LD · Markdown
FEI 3007513241 · Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device · Status: Active
| FEI Number | 3007513241 |
|---|---|
| Owner / Operator | Bioncise NV (#10028101) |
| Address | Bodemstraat 16/3, Wellen Limburg, B-3830, BE |
| Mandatory US Agent | Cook Myosite |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KNW |
| Regulation § (21 CFR) | 876.1075 |
| Proprietary names | Spirotome; Coramate |
Source: openFDA. Public-domain (CC0).