FDA Device Establishments · JSON-LD · Markdown
FEI 3016746283 · Manufacture Medical Device · Status: Active
| FEI Number | 3016746283 |
|---|---|
| Owner / Operator | Spectrum Medical SRL (#10069754) |
| Address | Via di Mezzo, 23, Mirandola Modena, 41037, IT |
| Mandatory US Agent | Spectrum Medical Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DTR |
| Regulation § (21 CFR) | 870.4240 |
| Proprietary names | Quantum PureFlow Standard Heat Exchanger; Quantum PureFlow Cardioplegia Heat Exchanger; QUANTUM SUPERPAC CARDIOPLEGIA |
Source: openFDA. Public-domain (CC0).