Identity
- Trade Name
- AtmosAir Velaris EUDAMED
- Device Name
- Pentaflex EUDAMED
- Model / Reference
- 120PM000/000 EUDAMED633042SL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05059441184423 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
- Slovenia 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 by Arjohuntleigh AB — Class I — 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 | 5060693520174W9 | Class I | Active |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (1)
- EUDAMED 5459aef6-bc9a-425e-96c6-f88db8abd731 61 fields · synced May 22, 2026