Elcam Medical Italy SpA
IT-MF-000012119 · Italy · Carpi (MO)
Elcam Medical Italy SpA is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 14 |
|---|
Most frequent device types declared: 060I3300-S, 060I3303-S, 06203302/S, 06203305-S, 06403300-S.
Among these devices, 14 are declared sterile.
Devices declared under this manufacturer
- Closed FLL red cap in blister packaging
- Closed FLL white cap in blister packaging
- Closed blue MLL/FLL cap in blister packaging
- Closed male luer lock cap, white
- Closed yellow MLL/FLL cap in blister packaging
- Connector MLL/MLL in blister packaging
- Double FLL in single blister
- Neutral Luer Lock Injection port in blister packaging
- Open MLL white cap in blister packaging
- Recirc. fll connector with closed cap
- Recirc. fll connector with vented cap
- Suspended FLL spike
Showing 12 of 14 declared devices.
Catalogue references include 060I3300-S, 060I3303-S, 06203305-S, 06403300-S, 06503300-S, 07103300/S.
European nomenclature codes declared: A070501, A070199, A07050201, A070103.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ELCAM MEDICAL ITALY SPA (IT) · FDA 3004960482 |
| Devices in EUDAMED | 14 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 7.1 % |
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. Elcam Medical Italy SpA is registered in the United States but was not found in the Canadian register.