Silvalea Limited
GB-MF-000003832 · United Kingdom · Newton Abbot
Silvalea Limited is registered in the European database on medical devices as a manufacturer, with 2 900 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 2 900 |
|---|
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- Amputee Hammock Poly Ex Ex Large
- Amputee Hammock, Commode, Poly Medium
- Arseus High Easy Poly Grey Loops Small
- Continental Easy Access Sling Low Cut Large
- Deluxe Rigid Stand Aid Sling Medium
- High Easy Poly Grey, DA-Clips White, Extra Small
- High Easy Poly Grey, DA-Clips White, Medium
- High Easy Poly No Padding, DA-Clips White, Medium
- High Easy, Parasilk, Navy, DA-Clips White, Large
- R/ment Allegro General Purpose Superfine Medium
- R/ment Quickfit Deluxe Arched Head Supp Poly Small
- R/ment Transporter Sling (Oxford Style) Medium
Showing 12 of 2 900 declared devices.
Catalogue references include 025FC-A-M, 062FLRG, CCR500PXXS, F10MXS, S11KM, S19KXS.
European nomenclature codes declared: V0805038002, V0805030102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SILVALEA LTD (GB) · FDA 3008720499 |
| Devices in EUDAMED | 2 900 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 2 900 |
|---|---|
| Found in the U.S. device database | 201 |
| Share | 6.9 % |
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. Silvalea Limited is registered in the United States but was not found in the Canadian register.