FDA Device Establishments · JSON-LD · Markdown
FEI 3008399755 · Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3008399755 |
|---|---|
| Owner / Operator | SLEE medical GmbH (#10055938) |
| Address | Am Neuberg 14, Nieder-Olm Rhineland-Palatinate, 55268, DE |
| Mandatory US Agent | Mercedes Medical |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | IDO |
| Regulation § (21 CFR) | 864.3010 |
| Proprietary names | SLEE CUT 6062; SLEE CUT 5062; SLEE CUT 4062 |
Source: openFDA. Public-domain (CC0).