ELMAC ELETTRONICA S.R.L.
IT-MF-000029501 · Italy · Tavullia
ELMAC ELETTRONICA S.R.L. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 5 |
|---|
Most frequent device types declared: ASAPSMED, ASCAMPOMATS_1NEED_MN, ASCAMPOMATS_1NEED_MN_PRO, EVO OMNIA, TRICOPAT.
Among these devices, 5 are declared active.
Catalogue references include AS-EVO-OMNI-MN-MP, ASAPSMED, ASCAMPOMATS_1NEED_MN, ASCAMPOMATS_1NEED_MN_PRO, TRICOPAT.
European nomenclature codes declared: Z12040203, Z120604, Z12069099, Z12019005.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ELMAC ELETTRONICA S.R.L. (IT) · FDA 3016899893 |
| Devices in EUDAMED | 5 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 3 |
|---|---|
| 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. ELMAC ELETTRONICA S.R.L. is registered in the United States but was not found in the Canadian register.