Energist
GB-MF-000021765 · United Kingdom · Swansea
Energist is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 8 |
|---|---|
| Class IIb | 15 |
Most frequent device types declared: NeoGen EVO [Black/Blue].
Among these devices, 14 are declared active.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- NeoGen
- NeoGen 25mm Nozzle
- NeoGen 5mm Nozzle
- NeoGen EVO
- NeoGen Footswitch
- NeoGen PSR
- NeoGen Regulator
Showing 12 of 23 declared devices.
Catalogue references include 230-027, 830-006, 830-009, 830-027, 830-040, 930-009.
European nomenclature codes declared: Z12040203.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ENERGIST LIMITED (GB) · FDA 3007353760 |
| Devices in EUDAMED | 23 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 23 |
|---|---|
| Found in the U.S. device database | 13 |
| Share | 56.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ENERGIST LIMITED |
North American profile: Both markets. Energist is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
GB25/00000090 | supplemented | 2030-03-08 |
GB25/00000090 | issued | 2030-05-08 |