HMC PREMEDICAL S.P.A.
IT-MF-000029438 · Italy · Mirandola (MO)
HMC PREMEDICAL S.P.A. is registered in the European database on medical devices as a manufacturer, with 162 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 99 |
|---|---|
| Class IIa | 63 |
Most frequent device types declared: n.a..
Among these devices, 159 are declared sterile.
Devices declared under this manufacturer
- BSmart®
Showing 12 of 162 declared devices.
Catalogue references include EP015LYW, LG12/80, LG6/40, MED501L, NGP5/55LY, NJP6/120L.
European nomenclature codes declared: G02020101, A088099, A030403, G02020102, A060399, A03010301.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | HMC Premedical S.p.A. (IT) · FDA 9613419 |
| Devices in EUDAMED | 162 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 162 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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. HMC PREMEDICAL S.P.A. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030101-00 | issued | 2029-09-26 |