Identity
- Trade Name
- NeoGen EUDAMEDNeoGen Regulator EUDAMED
- Device Name
- NeoGen Gas Regulator (CGA 580) EUDAMEDNeoGen Gas Regulator EUDAMED
- Model / Reference
- 830-003 EUDAMED830-040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060440520372 EUDAMED
- Basic UDI-DI
- B-05060440520372 EUDAMED506044052NeoGen-NR-001NG 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-05060440520372 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-05060440520372 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Energist
- EUDAMED SRN
- GB-MF-000021765
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 7f2f0d7e-e5b1-49d7-84a3-89a89dc4a786 61 fields · synced Aug 2, 2026
- EUDAMED f033fdc0-800f-437b-bcb8-f201d3d1e24b 61 fields · synced May 19, 2026