Brightwake Limited
GB-MF-000012039 · United Kingdom · Kirkby in Ashfield
Brightwake Limited is registered in the European database on medical devices as a manufacturer, with 127 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 90 |
|---|---|
| Class IIa | 35 |
| Class I | 2 |
Most frequent device types declared: 507906-000000, AS3669 - Large White, AS3835, CR3845, CR3938.
Among these devices, 97 are declared sterile, 2 active.
Authorised representative in the Union: CS Life Sciences Europe Ltd.
Devices declared under this manufacturer
- Actilite
- Advazorb
- Advazorb Areola
- Advazorb Border
- Advazorb Border Lite
- Eclypse Adherent Sacral
- Eclypse Boot
- Eclypse Border
- Eclypse Non-Backed
- Endotracheal Tube Holder- Long
- Physiotulle Ag
- Siltape
Showing 12 of 127 declared devices.
Catalogue references include AS3669, AS3765, CR3921, CR3939, CR3985, CR4191.
European nomenclature codes declared: M040499, M040204, R01058099, M04040701, M04040202, M050101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BRIGHTWAKE LTD (GB) · FDA 3007648359 |
| Devices in EUDAMED | 127 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 127 |
|---|---|
| Found in the U.S. device database | 71 |
| Share | 55.9 % |
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. Brightwake Limited is registered in the United States but was not found in the Canadian register.