Identity
- Trade Name
- AtmosAir Velaris EUDAMED
- Device Name
- Pentaflex EUDAMED
- Model / Reference
- 120PM000/000 EUDAMED633046IT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05059441181606 EUDAMED
- Basic UDI-DI
- 5060693520174W9 EUDAMED
- EMDN Code
- V080702 NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
AtmosAir Velaris, a revolutionary ventilator from ArjoHuntleigh AB, offers advanced mechanical ventilation in the comfort of your home. With its reliable performance and user-friendly interface, it's an ideal solution for individuals with respiratory conditions who require frequent support.
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 | 5060693520174W9 | Class I | Active |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (1)
- EUDAMED 7ec1b882-5707-40c6-804c-7ed3b822eeeb 61 fields · synced Jun 21, 2026