Identity
- Trade Name
- NeoGen EUDAMEDFDA UDI
- Generic Name
- Nitrogen plasma skin surface treatment system FDA UDI
- Device Name
- NeoGen Evo Trolley [Black / no Graphics] EUDAMEDNeogen Trolley Complete Blk FDA UDI
- Model / Reference
- 930-002 EUDAMEDTrolley Blk FDA UDI
- Description
- Neogen Trolley Complete Blk FDA UDI
Identifiers
- Catalog Number
- 930-002 FDA UDI
- Primary DI / UDI-DI
- 05060440520273 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060440520273 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 II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Northern Ireland 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
NeoGen by Energist — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060440520273 | 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 (2)
- EUDAMED 732e2cf6-7887-4018-9047-60013076ac75 61 fields · synced Jul 19, 2026
- FDA UDI 1a41a317-6997-4de2-9b88-99b67bd6fcfe 35 fields · synced May 29, 2026