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Aerogen Ultra Mouthpiece 10 Pack
EUDAMEDClass IIb (EU MDR)
Ref AG-AS7003-EUR
by Aerogen Ltd
Identity
- Trade Name
- Aerogen Ultra Mouthpiece 10 Pack EUDAMED
- Device Name
- Aerogen Ultra Mouthpiece 10 Pack EUDAMED
- Model / Reference
- AG-AS7003-EUR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391517936773 EUDAMED
- Basic UDI-DI
- 539151793AG00013WH EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
Aerogen Ultra Mouthpiece 10 Pack by Aerogen Ltd — 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 | 539151793AG00013WH | Class IIb | Active |
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Manufacturer
- Manufacturer
- Aerogen Ltd
- EUDAMED SRN
- IE-MF-000004597
Sources (1)
- EUDAMED c20f4261-436e-4c3d-928a-4298f163c798 61 fields · synced Jun 18, 2026