EUDAMED device
ISolate Stock Solution
EUDAMED device 00810195240378 · Irvine Scientific, LLC.
Key facts
| Primary DI | 00810195240378 |
|---|---|
| Trade name | ISolate Stock Solution |
| Device name | ISolate Stock Solution |
| Reference or catalog number | 99275 |
| Model | 99275-100mL |
| 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 | Jun 26, 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: