FDA Device Establishments · JSON-LD · Markdown
FEI 3014027738 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3014027738 |
|---|---|
| Owner / Operator | BIOSERENITY MEDICAL DEVICES GROUP (#10089585) |
| Address | 6/8 rue Jean Antoine de Baif, PARIS CEDEX 13 Ile-de-France, 75013, FR |
| Mandatory US Agent | VCLS Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GXY |
| Regulation § (21 CFR) | 882.1320 |
| Proprietary names | IceCap Neonate; IceCap 2 |
Source: openFDA. Public-domain (CC0).