GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.
ES-MF-000013779 · Spain · VALENCIA
GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A. is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 12 |
|---|
Most frequent device types declared: MAMMI SR, MAMMI DR, MAMMI COMPACT SR, MAMMI COMPACT DR, CAREMIBRAIN, SENTINELLA, SENTINELLA 102, SENTINELLA 102 HORUS, SENTINELLA HORUS, STD, LAP, HI-S.
Among these devices, 12 are declared reusable, 12 active, 3 with a measuring function.
Devices declared under this manufacturer
- CAREMIBRAIN
- GAMMAPRO HI-S
- GAMMAPRO LAP
- GAMMAPRO STD
- MAMMI COMPACT DR
- MAMMI COMPACT SR
- MAMMI DR
- MAMMI SR
- SENTINELLA
- SENTINELLA 102
- SENTINELLA 102 HORUS
- SENTINELLA HORUS
Catalogue references include FP-0040, FP-0055, FP-0202, FP-0203, FP-0205, FP-0600.
European nomenclature codes declared: Z11020401, Z11020101, Z11029001.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A. (ES) · FDA 3008962177 |
| Devices in EUDAMED | 12 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| Found in the U.S. device database | 8 |
| Share | 66.7 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A. is registered in the United States but was not found in the Canadian register.