FDA Device Establishments · JSON-LD · Markdown
FEI 3031191035 · Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3031191035 |
|---|---|
| Owner / Operator | Shandong Hengfeng Kerui Medical Equipment Co., Ltd (#10090457) |
| Address | Room 102, 1st Floor, and Room 202, 2nd Floor, Building 19, Liandong U Valley Life and Health City, No. 80, Tianjingshan 2nd Road, Huanxiu Street, Jimo District, Qingdao City Shandong, 266200, CN |
| Mandatory US Agent | Regrek LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NDP |
| Regulation § (21 CFR) | 872.3980 |
| Proprietary names | Abutment Screw, Multi-Unit Screw, Implant Analog, Impression Coping, Scan Body, Healing Cap, Hand Driver,; Lab hex Driver, Multi-Unit Hex Driver, Torque Wrench, Locator-Core Tool, Cover Cap |
Source: openFDA. Public-domain (CC0).