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Aerogen Solo Kit 15mm
EUDAMEDClass IIb (EU MDR)
Ref AG-AS3025Model AG-AS3010
by Aerogen Ltd
Identity
- Trade Name
- Aerogen Solo Kit 15mm EUDAMEDAerogen Solo Kit 15 mm EUDAMED
- Device Name
- Aerogen Solo Adult T-Piece EUDAMEDAerogen Solo T-Piece EUDAMED
- Model / Reference
- AG-AS3010 EUDAMEDAG-AS3025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391517937763 EUDAMED
- Basic UDI-DI
- 539151793AG00010WB EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa 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 Solo Kit 15mm 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 | 539151793AG00010WB | Class IIb | Active |
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Manufacturer
- Manufacturer
- Aerogen Ltd
- EUDAMED SRN
- IE-MF-000004597
Sources (2)
- EUDAMED 11680ca0-781b-4d49-9610-183c509c0046 61 fields · synced Jun 18, 2026
- EUDAMED a217da08-d79f-4adc-8e62-527db61c0439 61 fields · synced Jun 18, 2026