Eufoton Srl
IT-MF-000009227 · Italy · Trieste
Eufoton Srl is registered in the European database on medical devices as a manufacturer, with 75 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 54 |
|---|---|
| Class IIb | 21 |
Most frequent device types declared: EFLM-ME-04A-RD-S, EFLM-ME-04B-RD-S, EFLM-ME-04B-S, EFLM-ME-06A-RD-LL, EFLM-ME-06A-S.
Among these devices, 59 are declared sterile, 15 active.
Devices declared under this manufacturer
- EFLM-DT-01C-S
- EFLM-ELX-04C-RD-S
- EFLM-ELX-06C-RD-S
- EFLM-ME-02C-S
- EFLM-ME-02C1-S
- EFLM-ME-03C-S
- EFLM-ME-04B-RD-S
- EFLM-ME-06C1-S
- EFLM-ME-08C-S
- EFLM-ME-08C1-S
- EFLM-ME-10C-R
- EFLM-PT-06C-S
Showing 12 of 75 declared devices.
Catalogue references include EFLM-ME-02C-S, EFLM-ME-02C1-S, EFLM-ME-03C-S, EFLM-ME-04B-RD-S, EFLM-ME-08C-S, EFLM-ME-08C1-S.
European nomenclature codes declared: Z12011080, Z12011016.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 75 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 75 |
|---|---|
| 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: Neither register. Eufoton Srl was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1024592 1 | supplemented | 2029-05-15 |
ITD 1024592 1 | issued | 2029-05-15 |