Identity
- Trade Name
- AquaVENT® EUDAMED
- Device Name
- Humidification Chambers EUDAMED
- Model / Reference
- TF15 EUDAMEDAMHC1141 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15059443004733 EUDAMED
- Basic UDI-DI
- 506014624TF1535 EUDAMEDB-15059443004733 EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AquaVENT® by Armstrong Medical Limited — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 506014624TF1535 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 506014624TF1535 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Armstrong Medical Limited
- EUDAMED SRN
- XI-MF-000004092
Sources (2)
- EUDAMED da8bf3ff-2809-433e-8b1a-b0c93855ef46 61 fields · synced Jul 22, 2026
- EUDAMED 96569c72-3f7f-4b82-ab09-d46b72430a9c 61 fields · synced May 19, 2026