Identity
- Trade Name
- DIXION EUDAMED
- Device Name
- Ventilator EUDAMED
- Model / Reference
- Aeros 4800 EUDAMED4800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260664655534 EUDAMED
- Basic UDI-DI
- 4260664650408XJ EUDAMED
- Direct Marketing DI
- 04260664655534 EUDAMED
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dixion by Dixion Vertrieb medizinischer Geräte GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4260664650408XJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Dixion Vertrieb medizinischer Geräte GmbH
- EUDAMED SRN
- DE-MF-000005423
Sources (1)
- EUDAMED e2f7b844-2688-4182-aeb2-9d456c7acd28 61 fields · synced Jun 19, 2026