EUDAMED device
HYDRAFIL Delivery System
EUDAMED device 00195893039395 · ReGelTec Inc.
Key facts
| Primary DI | 00195893039395 |
|---|---|
| Trade name | HYDRAFIL Delivery System |
| Device name | HYDRAFIL Procedure Kit |
| Reference or catalog number | 610-0005 |
| Model | 610-0003 |
| Manufacturer | ReGelTec Inc. |
| Manufacturer SRN | US-MF-000025182 |
| Risk class | Class III |
| EMDN code | P09070201 |
| EMDN description | DISC PROSTHESES |
| Legislation | mdr |
| Implantable | Yes |
| Sterile | Yes |
| Single use | Yes |
| Status date | Jul 21, 2025 |
At a glance
- No 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: