Identity
- Trade Name
- NeoGen EUDAMEDNeoGen 5mm Nozzle EUDAMED
- Device Name
- NeoGen 5mm Nozzle (Blk) Qty 5 EUDAMEDNeoGen Nozzle EUDAMED
- Model / Reference
- 930-003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15060440520195 EUDAMED
- Basic UDI-DI
- B-15060440520195 EUDAMED506044052NeoGen-NZ-001R8 EUDAMED
- EMDN Code
- Z12040203 DERMAL REGENERATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMED
- Market of Registration
- Netherlands EUDAMED
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 by Energist — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-15060440520195 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-15060440520195 | Class IIb | 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 (2)
- EUDAMED da857eb0-1255-4563-9c90-cb739fa8f108 61 fields · synced Jul 11, 2026
- EUDAMED e323f497-1758-453f-a366-bb1e90219b3e 61 fields · synced May 18, 2026