Mediso Medical Imaging Systems Ltd.
HU-MF-000008325 · Hungary · Budapest
Mediso Medical Imaging Systems Ltd. is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 11 |
|---|---|
| Class IIa | 8 |
Among these devices, 17 are declared active, 17 with a measuring function.
Devices declared under this manufacturer
- AnyScan DUO SPECT/CT
- AnyScan DUO-Thera SPECT
- AnyScan DUO-Thera SPECT/CT
- AnyScan DUO-Thera SPECT/CT/PET
- AnyScan PET/CT
- AnyScan TRIO SPECT
- AnyScan TRIO SPECT/CT/PET
- AnyScan TRIO-IQMAX SPECT/CT
- AnyScan TRIO-IQMAX SPECT/CT/PET
- AnyScan TRIO-TheraMAX SPECT/CT/PET
- InterView FUSION
- InterView XP
Showing 12 of 19 declared devices.
Catalogue references include 5999884132196, 5999884132202, 5999884132226, 5999884132295, 5999884132301, 5999884132325.
European nomenclature codes declared: Z11020105,Z11020201, Z11020105,Z11020201,Z11020301, Z11020105, Z11020102, Z11029092, Z11020301.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 19 |
| Country of registration | Hungary |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 19 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 5.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDISO:MEDICAL IMAGING SYSTEMS |
North American profile: Canada only. Mediso Medical Imaging Systems Ltd. holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1662017-1 | supplemented | 2031-03-09 |