EUDAMED device
Disposable MRI Kit with Check Valve
EUDAMED device 00616258024301 · Bayer Medical Care Inc.
Key facts
| Primary DI | 00616258024301 |
|---|---|
| Trade name | Disposable MRI Kit with Check Valve |
| Device name | MRI Integral “T” with Check Valve for MEDRAD® Spectris MR Injector |
| Reference or catalog number | SQK 65VS |
| Manufacturer | Bayer Medical Care Inc. |
| Manufacturer SRN | US-MF-000007050 |
| Risk class | Class IIa |
| EMDN code | A02010401 |
| EMDN description | SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE |
| Legislation | mdr |
| Implantable | No |
| Sterile | Yes |
| Single use | Yes |
| Status date | Feb 5, 2026 |
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: