SurePulse Medical Ltd.
GB-MF-000002759 · United Kingdom · Nottingham
SurePulse Medical Ltd. is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 15 |
|---|
Among these devices, 15 are declared active, 15 with a measuring function.
Authorised representative in the Union: Advena Limited.
Catalogue references include SP-001-A-3, SP-127-A-1, SP-146-A-1, SP-159-A-1, SP-160-A-1, SP-161-A-1.
European nomenclature codes declared: Z12030299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SUREPULSE MEDICAL LIMITED (GB) · FDA 3018685978 |
| Devices in EUDAMED | 15 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 15 |
|---|---|
| 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. SurePulse Medical Ltd. is registered in the United States but was not found in the Canadian register.