FDA Device Establishments · JSON-LD · Markdown
FEI 3009585529 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3009585529 |
|---|---|
| Owner / Operator | Assure Tech. (Hangzhou) Co., Ltd. (#10040710) |
| Address | Building 4, No. 1418-50, Moganshan Road, Gongshu District, Hangzhou Zhejiang, 310011, CN |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JIN |
| Regulation § (21 CFR) | 862.1435 |
| Proprietary names | Blood Ketone Monitoring System for Keto Die; Blood Ketone Test Strips for Keto Diet |
Source: openFDA. Public-domain (CC0).