FDA Device Establishments · JSON-LD · Markdown
FEI 3034424132 · Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device · Status: Active
| FEI Number | 3034424132 |
|---|---|
| Owner / Operator | Rheme GmbH (#10091977) |
| Address | Kriegsbergstrasse 30, Stuttgart Baden-Wurttemberg, 70174, DE |
| Mandatory US Agent | Healthcare International Partners Llc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | FEN |
| Regulation § (21 CFR) | 876.1620 |
| Proprietary names | Air - Filled Rectal Urodynamic Catheter 7F - 8697880734693; Air - Filled Cystometry Catheter 7F - 8697880734624; Air - Filled Rectal Urodynamic Catheter 8F - 8697880734600; Air - Filled Cystometry Catheter 6F - 8697880734617; Air- Filled Rectal Urodynamic Transducer - 8697880734945; Air-Filled UPP Transducer - 8697880734938; Air - Filled Cystometry Catheter 8F - 8697880734679; Air-Filled Pressure Transducer - 8697880734952; Air - Filled UPP Catheter 7F - 8697880735218 |
Source: openFDA. Public-domain (CC0).