← Back to catalogue
NeoGen 25mm Nozzle
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 930-009510(k) K132754Ref 830-038Model NeoGen EVO [Black/Blue]Ref 830-027
by Energist
Identity
- Trade Name
- NeoGen 25mm Nozzle EUDAMEDNeoGen EUDAMED
- Device Name
- NeoGen Nozzle EUDAMEDNeoGen 25mm Nozzle (Blk) Qty 5 EUDAMEDNeoGen Evo System EUDAMED
- Model / Reference
- 930-009 EUDAMEDNeoGen EVO [Black/Blue] EUDAMED830-038 EUDAMED830-027 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15060440520201 EUDAMED05060440520310 EUDAMED05060440520136 EUDAMED
- Basic UDI-DI
- 506044052NeoGen-NZ-001R8 EUDAMEDB-15060440520201 EUDAMEDB-05060440520310 EUDAMEDB-05060440520136 EUDAMED
- 510(k) Number
- K132754 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
- EMDN Code
- Z12040203 DERMAL REGENERATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Market of Registration
- Netherlands EUDAMEDNorthern Ireland EUDAMEDFrance EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NeoGen 25mm Nozzle by Energist — Class I — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 506044052NeoGen-NZ-001R8 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K132754 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 506044052NeoGen-NZ-001R8 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Energist
- EUDAMED SRN
- GB-MF-000021765
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (5)
- EUDAMED 3ef91040-17eb-4674-9258-4771193b2c2b 61 fields · synced Jul 24, 2026
- FDA 510(k) K132754 24 fields · synced May 18, 2026
- EUDAMED 700306ca-9943-4f85-9acc-61ee033128ea 61 fields · synced Jul 10, 2026
- EUDAMED 2c586421-ce5b-4dd7-9b9c-dfde820cc6b9 61 fields · synced Jul 23, 2026
- EUDAMED cbff7d1f-0ca2-41cd-b678-c4eb4c4d41cd 61 fields · synced Jul 24, 2026