Energist
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000021765
Energist is a medical device manufacturer based in the United Kingdom, with 3 devices listed in EUDAMED (EU Class I and IIb) as of 15 Nov 2026.
- Devices
- 3
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 3
- Device classes
- EU Class I 2
- EU Class IIb 1
- Top EMDN categories
- Sites and related companies
- Advena Limited authorised representative
- Identifiers
- EUDAMED SRN GB-MF-000021765
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA establishment
- Authorised rep.
- Advena LimitedMT
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.
Catalogue
NeoGen Ref 930-025
Regimes: CE MDD Registry: EUDAMEDNeoGen Ref 930-026
Regimes: CE MDR Registry: EUDAMEDNeoGen Footswitch Ref 230-027
Regimes: CE MDR CE MDD Registry: EUDAMED
Company details
- EUDAMED SRN
- GB-MF-000021765
- EUDAMED status
- Active
- EUDAMED registered name
- Energist
- Registered address
- Clos Llyn Cwm, sa6 qty, Swansea, United Kingdom (ex Northern Ireland)
- Website
- www.energist.com
- info@energist.com
- Phone
- +441792798768
- PRRC contact
- Adam Stephens
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 8 Mar 2030
SGS Belgium NV 1639 2 certificates
- GB25/00000090 Active
Quality management system EU MDR
- Issued
- 20 Jan 2026
- Expires
- 8 May 2030
- GB25/00000090 Active
Quality management system EU MDR
- Issued
- 8 May 2025
- Expires
- 8 Mar 2030
- Reason
- Change approved
FDA establishments
- Energist, Ltd. GB
Frequently asked questions
How many devices does Energist have in the registry?
The registry currently lists 3 devices for Energist. Devices recorded under merged duplicate company entries are counted once.
Which registries list Energist's devices?
Among its 3 most recently registered devices, Energist has devices listed in EUDAMED (3 devices).
What risk classes do Energist's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Energist's devices are Class I and Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Energist?
EUDAMED lists 2 certificates for Energist (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 20 Jan 2026.
What are the newest devices from Energist in the registry?
The most recently registered devices listed for Energist include NeoGen and NeoGen Footswitch.
Which FDA establishments are linked to Energist?
1 FDA establishment is linked to Energist in the registry; they are listed on the company page.