Smirthwaite Limited
GB-MF-000010683 · United Kingdom · Wakefield
Smirthwaite Limited is registered in the European database on medical devices as a manufacturer, with 153 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 153 |
|---|
Most frequent device types declared: Asiento Chair, Combi, Easi-Lift Changing bench, Heathfield, Hi-Riser Changing Bench.
Authorised representative in the Union: Evolution Healthcare Ltd.
Devices declared under this manufacturer
- Asiento Chair - Size 3, Dynamic Backrest
- Brookfield Size 2 High Back
- Combi with fixed armrests SKU - Size 1
- Combi with fixed armrests SKU - Size 2
- Combi with fixed armrests SKU - Size 3
- Easi-Lift Changing bench - Size 5
- Heathfield Size 2 Fixed Arm
- Hi-Riser Changing bench - Size 2 - Stainless Steel
- Juni Size 1 - Blue
- Juni Size 4 - Blue
- Juni Size 4 - Red
- Samba Size 1 - Hi-lo Base
Showing 12 of 153 declared devices.
Catalogue references include 11136, 16014, 16031, 16034, 3085, 6574.
European nomenclature codes declared: Y180939, Y093312, Y091203, Y093303.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SMIRTHWAITE LTD (GB) · FDA 3010605477 |
| Devices in EUDAMED | 153 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 153 |
|---|---|
| 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. Smirthwaite Limited is registered in the United States but was not found in the Canadian register.