NeoGen
Ref 830-003, 830-040
NeoGen (830-003) is a medical device (EU MDD Class IIb; EU MDD Class I; EMDN category dermal regeneration equipment) made by Energist, Ltd., registered in EUDAMED on 21 Jul 2022 (Basic UDI-DI B-05060440520372), active as of 25 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-05060440520372 05060440520372 | Date21 Jul 2022 | StatusActive |
Official records
- EUDAMED public site B-05060440520372
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Trade name
- NeoGenNeoGen Regulator
- Device name
- NeoGen Gas Regulator (CGA 580)NeoGen Gas Regulator
- Model / reference
- 830-003, 830-040
- Primary DI / UDI-DI
- 05060440520372
- Basic UDI-DI
- B-05060440520372, 506044052NeoGen-NR-001NG
- EMDN code
- Z12040203 Dermal regeneration equipment
- Device class
- Class IIbClass I
- EU registration type
- Legacy device (under a directive)Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- GB-MF-000021765
- Authorised representative
- Advena Limited MT-AR-000000234
Similar devices in this category
Other devices filed under DERMAL REGENERATION EQUIPMENT.
- ALD FS70001 by FORMATK SYSTEMS LTD
- ARTEMIS 380800000333 by NOVAVISION GROUP
- HR-Mini FS80021 by FORMATK SYSTEMS LTD
- ZIONIC PRO MAX M105/1 by Termosalud, S.L.
- NEUTRAL RETURN PLATE 34D A5288AE by Termosalud, S.L.
- DAFNE 380800000327 by NOVAVISION GROUP
- Tixel Periorbital Handpiece MPH00001 by NOVOXEL LTD
- Tixel Handpiece MSH00001 by NOVOXEL LTD
- CELLIMPACT 27100.0100 by Storz Medical AG
- DUOLITH SD1 T-TOP 21362.1000 by Storz Medical AG