EUDAMED device
ISolate Ready to Use Density Gradient Medium at Two Concentrations
EUDAMED device 00810195240361 · Irvine Scientific, LLC.
Key facts
| Primary DI | 00810195240361 |
|---|---|
| Trade name | ISolate Ready to Use Density Gradient Medium at Two Concentrations |
| Device name | ISolate Ready to Use Density Gradient Medium at Two Concentrations |
| Reference or catalog number | 99264 |
| Model | 99264-2x100mL |
| Manufacturer | Irvine Scientific, LLC. |
| Manufacturer SRN | US-MF-000007514 |
| Risk class | Class IIb |
| EMDN code | U08020502 |
| EMDN description | MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION |
| Legislation | mdd |
| Implantable | No |
| Sterile | Yes |
| Single use | Yes |
| Status date | Jul 15, 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: