SLE Ltd
GB-MF-000004155 · United Kingdom · Croydon
SLE Ltd is registered in the European database on medical devices as a manufacturer, with 84 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 74 |
|---|---|
| Class IIa | 10 |
Among these devices, 3 are declared sterile, 77 active, 73 with a measuring function.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- Balloon Test Lung - Single Use - Qty 1
- Balloon Test Lung - Single Use - Qty 10
- SLE6000 - Greece (Packaging)
- SLE6000 - Poland (Packaging)
- SLE6000C - (Device)
- SLE6000C - Netherlands (Packaging)
- SLE6000C - Poland (Packaging)
- SLE6000C - Slovakia (Packaging)
- SLE6000H - Slovenia (Packaging)
- SLE6000N - (Device)
- SLE6000N - France (Packaging)
- SLE6000N - Greece (Packaging)
Showing 12 of 84 declared devices.
Catalogue references include LSU003, N2328, N2328/10, N5402-REV2, Z6000, Z6000C.
European nomenclature codes declared: Z1203010503, Z1203010580, Z12080405, Z1203019080.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 84 |
| 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 | 84 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SLE LTD. |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2024-08-01 |
Licence types: System (1).
Licensed under: INSPIRE RPAP GENERATOR.
North American profile: Canada only. SLE Ltd holds a Canadian licence but was not found in the U.S. register.