Fresco International 2005, S.A.
ES-MF-000010728 · Spain · Barcelona
Fresco International 2005, S.A. is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 23 |
|---|
Devices declared under this manufacturer
- Gel Bunion Sleeve
- Gel Tube-Ribbed, Small
- Gel bunion spreader & ring, Small
- Gel heel, 2 hardness, Large
- Gel heel, 2 hardness, Medium
- Gel heel, 2 hardness, Small
- Gel toe spreader & bunion protector
- Met & Bunion Protector Sleeve, Large
- Protecteur oignon tissu
- Pure Gel Digital Cap, Large
- Pure Gel Digital Cap, Medium
- Pure Gel Ring, Large
Showing 12 of 23 declared devices.
Catalogue references include F-00001-01, F-00003-01G, F-00013-01G, F-00033-03CNP, F-00042-54CNP, F-00051-21CJU.
European nomenclature codes declared: Y090699, Y061203.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | FRESCO INTERNATIONAL 2005 S.A. (ES) · FDA 3005132313 |
| Devices in EUDAMED | 23 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 23 |
|---|---|
| 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. Fresco International 2005, S.A. is registered in the United States but was not found in the Canadian register.