FDA Device Establishments · JSON-LD · Markdown
FEI 3014345398 · Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device · Status: Active
| FEI Number | 3014345398 |
|---|---|
| Owner / Operator | Delcon Srl (#10057182) |
| Address | Via Zanica 19/F/I, Grassobbio Bergamo, 24050, IT |
| Mandatory US Agent | ISOPLAN USA |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KSD |
| Regulation § (21 CFR) | 864.9750 |
| Proprietary names | HWELD-T.DB0 HemoWeld-T Bench tube sealer for medical PVC tubes; HWG21 HemoWeld Gun Handgun; HWG20H HemoWeld-Gun Portable sealer for blood bag tubes - Holder Kit; HWG22 HemoWeld Gun Power Unit; HWG20V HemoWeld-Gun Portable sealer for blood bag tubes - Case Kit; HWELDC.DB0 HemoWeld-Slim Sterile tube bench top sealer; HWELD-B.DB0 HemoWeld-B - Mobile tube sealer for medical PVC tubes; HWELD-B.DB0G WELD B - Mobile tube sealer for medical PVC tubes; ACC000066 ROMA charger; HWG20 HemoWeld-Gun |
Source: openFDA. Public-domain (CC0).