Quadralene Ltd
GB-MF-000016550 · United Kingdom · Derby
Quadralene Ltd is registered in the European database on medical devices as a manufacturer, with 119 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 119 |
|---|
Authorised representative in the Union: MAQUET GmbH.
Catalogue references include 6036009101, DS024/1, DSP03X10, DSP04X10, DSP05X20, DSP16.
European nomenclature codes declared: S01010101, D0899, D0801, V9099, T030199, D0502.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | QUADRALENE LTD (GB) · FDA 3040277182 |
| Devices in EUDAMED | 119 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 119 |
|---|---|
| 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. Quadralene Ltd is registered in the United States but was not found in the Canadian register.