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AirPhysio
EUDAMEDClass I (EU MDR)
Ref 9369998150427Model AirPhysio Average Lung Device
Identity
- Trade Name
- AirPhysio EUDAMED
- Device Name
- AirPhysio OPEP Device EUDAMED
- Model / Reference
- AirPhysio Average Lung Device EUDAMED9369998150427 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B99893699980830601/$AN-2109090091222X EUDAMED
- Basic UDI-DI
- ++B99836999802150505J EUDAMED
- Direct Marketing DI
- 9359191093699981504E EUDAMED
- EMDN Code
- R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
AirPhysio by Airphysio Pty. Ltd. — 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 | ++B99836999802150505J | Class I | Active |
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Manufacturer
- Manufacturer
- AirPhysio Pty Ltd
- EUDAMED SRN
- AU-MF-000052052
- Authorised Representative
- Luft For Life Österreich Ltd AT-AR-000020403
Sources (1)
- EUDAMED bd1720bf-7722-45ff-a6ca-b44921e7f788 61 fields · synced May 24, 2026