FDA Device Establishments · JSON-LD · Markdown
FEI 3014649053 · Manufacture Medical Device · Status: Active
| FEI Number | 3014649053 |
|---|---|
| Owner / Operator | Sterilance Medical (Suzhou) Inc. (#9070037) |
| Address | No.168 PuTuoShan Road, New District, Suzhou Jiangsu, 215153, CN |
| Mandatory US Agent | REGULATORY INSIGHT, INC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QRK |
| Regulation § (21 CFR) | 878.4850 |
| Proprietary names | ONETOUCH® UltraSoft®2 Disposable Blood Lancet; Soft Disposable Blood Lancet |
Source: openFDA. Public-domain (CC0).