Savantini Ltd
GB-MF-000011959 · United Kingdom · Hull
Savantini Ltd is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 14 |
|---|
Most frequent device types declared: Kegel8 Anal Dilators, Kegel8 Pelvic Therapy Wand, Kegel8 Vaginal Dilators, Prostate Cradle.
Authorised representative in the Union: European Healthcare & Device Solutions Ltd..
Devices declared under this manufacturer
- Kegel8
- Maxhim
Showing 12 of 14 declared devices.
Catalogue references include 13928-SIZE2, 13928-SIZE3, 13928-SIZE4, 13963, 13965, 13965-SIZE1.
European nomenclature codes declared: L040902, L0509020101, U99, U0899.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 14 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| 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. Savantini Ltd was not found in either the U.S. or the Canadian register.