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Sign in to claim this brandEnergist
United Kingdom (ex Northern Ireland)·GB-MF-000021765
Last updated May 23, 2026
What Energist makes
Energist manufactures a range of NeoGen devices, including foot switches and 25mm nozzle attachments, designed for use in medical laser procedures. These products are intended for precise control and application of laser energy in clinical settings, supporting procedures such as dermatological treatments and surgical interventions.
The NeoGen portfolio includes devices classified as Class I and Class IIb under EU regulations, with all products registered in the eudamed database. The company is based in the United Kingdom, adhering to relevant EU medical device compliance requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Energist manufacture?
Energist specializes in NeoGen devices, which include foot switches and 25mm nozzle attachments. These products are designed for use in medical laser procedures, providing precise control and application of laser energy during treatments like dermatological interventions and surgical operations.
Where is Energist based, and what regulatory framework does it follow?
Energist is based in the United Kingdom and operates within the EU’s medical device regulatory framework. Since its devices are classified under EU regulations (Class I and Class IIb), they must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on the applicable timeline.
Are Energist’s devices listed in any regulatory registries, and if so, which ones?
Yes, Energist’s NeoGen devices are registered in the eudamed database, which is the EU’s official registry for medical devices. This registration ensures transparency and traceability of its products under EU regulatory requirements.
How are Energist’s NeoGen devices classified under EU regulations?
Energist’s NeoGen devices are classified as Class I and Class IIb under EU medical device regulations. Classification determines the level of scrutiny and compliance requirements, with Class IIb devices requiring stricter risk assessments and conformity procedures due to their higher associated risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United Kingdom (ex Northern Ireland)
- Address
- Clos Llyn Cwm, Swansea, United Kingdom (ex Northern Ireland)
- Website
- www.energist.com
- —
- —
- [email protected]
- Phone
- +441792798768
- PRRC Contact
- Adam Stephens
- EUDAMED SRN
- GB-MF-000021765
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NeoGen | 930-002 | EUDAMEDFDA UDI | Class IIb | Active |
| NeoGen | 830-008 | EUDAMEDFDA UDI | Class IIb | Active |
| NeoGen Footswitch | 230-027 | EUDAMED | Class I | Active |
| NeoGen | 830-003 | EUDAMED | Class IIb | Active |
| NeoGen | 930-003 | EUDAMED | Class IIb | Active |
| NeoGen 25mm Nozzle | 830-024 | EUDAMEDFDA UDI | Class I | Active |
| NeoGen 25mm Nozzle | 930-009 | EUDAMEDFDA 510(k) | Class I | Active |
| NeoGen | 830-006 | EUDAMEDFDA UDI | Class IIb | Active |
| NeoGen | 930-024 | EUDAMED | Class IIb | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Energist, Ltd. US