Identity
- Trade Name
- NeoGen EUDAMEDFDA UDINeoGen 5mm Nozzle EUDAMED
- Generic Name
- Nitrogen plasma skin surface treatment system FDA UDI
- Device Name
- NeoGen 5mm Nozzle Blk EUDAMEDNeoGen Nozzle EUDAMEDNeoGen 5mm 1x Nozzle (Black) FDA UDI
- Model / Reference
- 830-006 EUDAMEDNeoGen 5mm 1x Nozzle (Black) FDA UDI
- Description
- NeoGen 5mm 1x Nozzle (Black) FDA UDI
Identifiers
- Catalog Number
- 830-006 FDA UDI
- Primary DI / UDI-DI
- 05060440520198 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060440520198 EUDAMED506044052NeoGen-NZ-001R8 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 IIb EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- France EUDAMEDNetherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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 by Energist — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05060440520198 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-05060440520198 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Energist
- EUDAMED SRN
- GB-MF-000021765
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED c39186d1-3ddd-4b55-a58f-3e6b5fb76d84 61 fields · synced Jul 17, 2026
- EUDAMED b73b769c-2623-4ef3-8b02-77820a6f5cde 61 fields · synced May 18, 2026
- FDA UDI ef897491-7fab-4558-a314-673234b36841 36 fields · synced May 30, 2026