FDA Device Establishments · JSON-LD · Markdown
FEI 3002806337 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3002806337 |
|---|---|
| Owner / Operator | SB-KAWASUMI LABORATORIES, INC. (#8031539) |
| Address | 27-4, Aza Nakajimashita, Souzen-machi, Tsuchizakiminato, Akita, 011-8510, JP |
| Mandatory US Agent | SUMITOMO PLASTICS AMERICA, INC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KRA |
| Regulation § (21 CFR) | 870.1210 |
| Proprietary names | SwiftNINJA Microcatheter |
Source: openFDA. Public-domain (CC0).