F.L. Medical s.r.l. Unipersonale
IT-MF-000013918 · Italy · Torreglia (PD)
F.L. Medical s.r.l. Unipersonale is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: 21150, 2115001, 2115003, 2115005, 2115007.
Among these devices, 13 are declared sterile.
Devices declared under this manufacturer
- PROMED
- URINTAINER
Showing 12 of 17 declared devices.
Catalogue references include 21150, 2115001, 2115003, 2115005, 2115007, 21151.
European nomenclature codes declared: W050301020102, W05010203.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | F.L. MEDICAL S.R.L. UNIPERSONALE (IT) · FDA 3009520931 |
| Devices in EUDAMED | 17 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 17 |
|---|---|
| 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. F.L. Medical s.r.l. Unipersonale is registered in the United States but was not found in the Canadian register.