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Aerogen Ultra with I-Guard™ Aerosol Mask (Ped)
EUDAMEDClass IIb (EU MDR)
Ref AG-AS7002-EURModel AG-AS7001-EUR
by Aerogen Ltd
Identity
- Trade Name
- Aerogen Ultra with I-Guard™ Aerosol Mask (Ped) EUDAMED
- Device Name
- Aerogen Ultra with I-Guard™ Aerosol Mask (Adult) EUDAMED
- Model / Reference
- AG-AS7001-EUR EUDAMEDAG-AS7002-EUR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391517937893 EUDAMED
- Basic UDI-DI
- 539151793AG00020WE 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 with I-Guard™ Aerosol Mask (Ped) 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 | 539151793AG00020WE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Aerogen Ltd
- EUDAMED SRN
- IE-MF-000004597
Sources (1)
- EUDAMED 25e94082-e50f-4eab-a569-48200473d509 61 fields · synced Jun 18, 2026