Identity
- Trade Name
- NeoGen 25mm Nozzle EUDAMEDNeoGen EUDAMEDFDA UDI
- Generic Name
- Nitrogen plasma skin surface treatment system FDA UDI
- Device Name
- NeoGen Nozzle EUDAMEDNeoGen 25mm Nozzle Blk EUDAMEDNeoGen 25mm 1x Nozzle (Black) FDA UDI
- Model / Reference
- 830-024 EUDAMEDNeoGen 25mm 1x Nozzle (Black) FDA UDI
- Description
- NeoGen 25mm 1x Nozzle (Black) FDA UDI
Identifiers
- Catalog Number
- 830-024 FDA UDI
- Primary DI / UDI-DI
- 05060440520204 EUDAMEDFDA UDI
- Basic UDI-DI
- 506044052NeoGen-NZ-001R8 EUDAMEDB-05060440520204 EUDAMED
- 510(k) Number
- K132754 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12040203 DERMAL REGENERATION EQUIPMENT EUDAMED
- GMDN Term
- Nitrogen plasma skin surface treatment system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMEDFrance EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
NeoGen 25mm Nozzle by Energist — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 506044052NeoGen-NZ-001R8 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 506044052NeoGen-NZ-001R8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Energist
- EUDAMED SRN
- GB-MF-000021765
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 9bcebe4b-e2c2-4b79-9162-aa3a2134fc0a 61 fields · synced Jul 22, 2026
- EUDAMED 60f272a9-4433-4236-aecb-13189ad57fd0 61 fields · synced May 18, 2026
- FDA UDI 584bbc64-f57a-4e85-9d1f-f314b4b5b08e 36 fields · synced May 30, 2026