FDA Device Establishments · JSON-LD · Markdown
FEI 3004149774 · Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3004149774 |
|---|---|
| Owner / Operator | SENTEC AG (#9064082) |
| Address | RINGSTRASSE 39, THERWIL Basel-Landschaft, CH-4106, CH |
| Mandatory US Agent | Imagenix, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | LKD, DPZ, DQA |
| Regulation § (21 CFR) | 868.2480, 870.2710, 870.2700 |
| Proprietary names | SDMS SenTec Digital Monitoring System; RSS Series SpO2 Soft Sensors; EC-MI Ear Clip; V-STATS PC Software including V- CareNeT; MAR-MI Multi-site Attachment Ring; MAR-SF Multi-site Attachment Ring; VS-A/P/N V-SignTM Sensor 2 |
Source: openFDA. Public-domain (CC0).