Metaltronica SpA
IT-MF-000014684 · Italy · Pomezia
Metaltronica SpA is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 6 |
|---|
Most frequent device types declared: LILYUM.
Among these devices, 6 are declared active.
Devices declared under this manufacturer
- HELIANTHUS
- HELIANTHUS C
- HELIANTHUS DBT
- LILYUM
- MAMMO 10
Catalogue references include M-HELI/2D, M-HELI/CMP, M-HELI/DBT, M-LILYUM, M-MAMMO 10.
European nomenclature codes declared: Z11030202, Z11030201.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Metaltronica Spa (IT) · FDA 3009868110 |
| Devices in EUDAMED | 6 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 16.7 % |
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. Metaltronica SpA is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
046/MDR | issued | 2027-08-01 |
046/MDR | supplemented | 2027-08-01 |