Medis Medical Imaging Systems bv
NL-MF-000002670 · Netherlands · Leiden
Medis Medical Imaging Systems bv is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIa | 8 |
|---|
Most frequent device types declared: 20240115, Medis QFR XA, 2025, 2022, 2024.
Among these devices, 6 are declared active, 8 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | MEDIS MEDICAL IMAGING SYSTEMS, B.V. (NL) · FDA 9614587 |
| Devices in EUDAMED | 8 |
| Country of registration | Netherlands |
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 00044-A | issued | 2029-06-27 |