EUDAMED device
ComforTEC
EUDAMED device 00816734022252 · Diversatek Healthcare
Key facts
| Primary DI | 00816734022252 |
|---|---|
| Trade name | ComforTEC |
| Device name | ZepHr Reflux Monitoring System |
| Reference or catalog number | ZAI-BS-01 |
| Manufacturer | Diversatek Healthcare |
| Manufacturer SRN | US-MF-000025177 |
| Risk class | Class IIa |
| EMDN code | Z120704 |
| EMDN description | GASTRIC PH MONITOR |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | Yes |
| Status date | Oct 17, 2025 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: